Clinical Studies

❶临床药理总监(1人)

工作职责:

1、负责指导临床方案中临床药理相关研究内容的撰写,为药物临床安全性及有效性研究提供相关技术支持。

2、评估创新药物的临床前数据,并运用相应模型手段预测药物的人体处置特点,指导早期临床研究的剂量设计。

3、负责临床药效学研究(PD)的设计和实施督导,如生物标记物(biomarker)和终点的选择等。

4、协调解决跨部门合作中出现的与药物安全性、有效性及药物代谢动力学相关的问题。

5、与临床专家及审评专家进行专业沟通,为临床研究设计提供科学和法规支持。

6、负责相应团队的建设与管理。

任职要求:

1、学历要求:博士学历。

2、专业要求:临床药理相关专业。

3、工作经验:

(1)至少5年以上临床药理相关工作经验。

(2)具有早期临床试验方案设计经验,主导完成过首次人体临床试验(FIH)、剂量爬坡、药物代谢动力学(PK)等研究设计。

4、能力要求:

(1)精通临床药理和药物代谢动力学相关知识,熟悉药物开发流程,具有一定的临床研究经验。

(2)熟练运用GastroPlus, SimCYP等模型工具预测人体PK/PD特点。

(3)熟悉全球药物研发中临床药理相关法规政策,能与监管部门沟通协调研究过程中各项事宜。

(4)了解常用的数据处理和统计分析方法。

5、职业素养:积极敬业、主动进取、责任感强、正直向上。

6、语言要求:良好的中、英文阅读和写作能力。

 

❷后期临床总监(2人)

工作职责:

1、负责药物的Ⅱ、Ⅲ期临床研究方案设计,推动药物的后期临床研究顺利进行。

2、对早期临床研究数据做出评估和反馈,组织相关内、外部讨论,决策后续方案及临床策略。

3、与临床专家及审评专家进行专业沟通,为临床研究设计提供科学和法规支持。

4、通过与相关团队的积极互动,为新的研究方向和新项目的研究提供临床医学知识和经验协助。

5、负责相应团队的培训和建设、指挥与管理。

任职要求:

1、学历要求:硕士或以上学历。

2、专业要求:临床医学相关专业背景。

3、工作经验:

(1)具有主治医生及以上资格,并具有硕士以上研究能力的肿瘤、内分泌、心血管、血液、神经、精神疾病等内科专业医生,负责过药物临床研究者优先。

(2)或临床医学等相关专业,在大型制药企业5年以上肿瘤、糖尿病、肝炎等疾病药物的临床方案设计经验,负责过肿瘤新药方案设计者优先。

4、能力要求:

(1)具有扎实的临床医学知识;对肿瘤、糖尿病、肝炎等疾病领域的临床研究有丰富的经验。

(2)具有对文献或研究结果进行综合分析、判断的能力。

(3)熟悉药物研发基本流程及相关政策法规的基本知识。

5、职业素养:积极敬业、主动进取、责任感强、正直向上。

6、语言要求:良好的中、英文阅读和写作能力。

 

注册申报及医学撰写负责人(Head, Regulatory Submission and Medical Writing)

职位描述:

1、  指导并全面负责注册申报相关资料的撰写、修订和审核工作

2、  指导并负责临床试验相关的资料的撰写、修订和审核工作

3、  指导并负责其它医学支持类相关文案的撰写、修订和审核工作

4、  指导并负责与内外部相关部门的沟通中的相关医学文案的撰写、修订和审核工作

任职要求:

1、医、药和/或法规相关专业,博士及以上学历;

2、10年以上医药工业界医学写作、注册申报等相关工作经验、团队管理经验及跨国公司工作经验者优先;

3、中/美IND及NDA申报经验者优先;

4、具有临床试验操作经验者优先

5、中英文写作及交流能力优秀者优先;

6、具备团队领导能力,良好的组织及计划能力,良好的人际交往能力。

本职位在中、美两国同时招聘,工作地点可以根据应聘人的情况及负责项目的情况决定;本职位向中美临床科学负责人,临床研究中心执行副总裁汇报。

 

生物统计总监-1人

工作职责:

1、审核临床试验方案的统计内容并为方案设计提供科学合理的统计学支持。

2、统筹临床试验统计相关工作的实施,并做好质量控制。

3、指导撰写数据验证计划和数据盲态审核报告,并协调数据审核会议高效且顺畅完成。

4、建立完善的统计分析SOP体系与团队发展规划。

任职要求:

1、学历要求:硕士及以上学历。

2、专业要求:生物统计、流行病与卫生统计学相关专业。

3、工作经验:

(1)5年以上制药企业统计分析工作经验或高校统计教研室任职经历,大型药企任职过统计负责人者优先。

(2)5年以上统计团队管理经验。

4、能力要求:

(1)熟悉ICH与CFDA临床试验生物统计相关的法规和技术指导原则。

(2)有清晰的编程思路,精通SAS编程,能够熟练运用SAS宏语言。

(3)有扎实的概率论与数理统计基础,精通常用统计模型的构建。

(4)熟练掌握统计分析计划与统计分析报告的撰写要领。

5、职业素养:积极敬业、责任感强,具备良好的团队协作能力与沟通能力。

6、语言要求:具备良好的中、英文沟通及写作能力。

 

药物警戒总监

药物警戒从用药者安全出发,发现、评估、预防药品不良反应。要求有疑点就上报,不论药品的质量、用法、用量正常与否,更多的重视以综合分析方法探讨因果关系,容易被广大报告者接受。

药物警戒的主要工作内容包括:

①早期发现未知药品的不良反应及其相互作用;

②发现已知药品的不良反应的增长趋势;

③分析药品不良反应的风险因素和可能的机制医学教育网/搜集整理;

④对风险/效益评价进行定量分析,发布相关信息,促进药品监督管理和指导临床用药。

职位描述:

岗位职责:
1. 及时接收、审查和处理来自临床试验过程中各方的药物安全性数据,并对重要的药物不良反应进行跟踪、监管和报告;
2. 严重不良反应(SAE)或非预期的不良事件的相关资料进行收集、整理、汇总,有必要需跟研究者进行沟通;
3. 按照相关要求将SAE上报至国家及地方药品监管部门,并对发生的SAE/非预期的不良事件进行跟踪和报告,确保所有报告在规定时间内上报给相关单位;
4. 查阅中国药物警戒条例,确保递交过程符合现行法规要求;
5. 为项目组其他成员进行指导和培训。

任职资格:
1. 临床医学或药学相关专业本科及以上学历,肿瘤医生优先考虑;
2. 具备临床相关经验,能够与医生进行学术上的交流;
3. 5年在制药企业的相关工作经验;
4. 英语水平良好,沟通无问题;
5. 能够使用常规的办公软件。

 

BE运营版块-BE运营总监1人

工作职责:

1、负责统筹管理并组织BE项目的临床实施,根据公司部署调配团队资源,确保重大项目快速、高质量完成。

2、对BE项目进行全面的质量控制与管理,督导按时完成临床试验的快速启动、实施及结题工作。

3、负责拓展并维护专家/医院资源,与相关审评专家、临床专家和其他临床研究资源沟通与交流,制定正确的临床实施方案,保障BE研究顺利进行。

4、负责BE运营团队的构建和培训管理体系,建立并完善相关SOP;负责团队建设、培训与管理。

5、参与药物临床研究方案制定、临床研究相关材料的审核。

任职要求:

1、专业背景要求:

(1)医学、药学、生物学等相关专业硕士及以上学历。

(2)大型制药企业5年以上BE临床项目实施经验,3年以上项目管理工作经验和团队管理经验。

2、能力要求:

(1)具备丰富的BE临床运营经验,精通BE临床研究全过程,熟悉国内外药物临床研究的法规政策,及临床研究发展与现状。

(2)拥有丰富的行业资源,有能力对临床资源进行协调,并能及时协调解决临床研究中的各种问题。

(3)具有优秀的沟通协调、资源整合能力、策划能力及团队管理能力,具有较强的领导力、执行力,问题解决能力及应急预案管理能力。

3、语言要求:具备优秀的中文写作和表达能力,良好的英文文献阅读能力。

 

临床策略总监The Clinical Strategy Lead (CSL)

The Clinical Strategy Lead (CSL) will be the GCD (global clinical development ) representative for providing strategic clinical direction for the life cycle of products.

This will be accomplished by CSL awareness of priorities to align clinical resources accordingly and plan ahead. The CSL will have a clear understanding of the company’s current global investment in evidence collection as well as company’s strategic goals.

The CSL is responsible for developing “Global Clinical Evidence Plans” including short and long term strategy, development of methodologically sound clinical study synopsis and clinical study plans with regulatory strategy and pathway, including product’s targeted indication, population, efficacy endpoint, competitor’s landscape.

GCD representative for one or more franchise teams and will actively participate in the respective regular franchise committee meeting and GCD meetings

Liaise with pre-clinical teams and medical information and clinical operation personnel, to ensure effective study alignment with product strategy throughout the design, implementation and lifetime of the study/ies.

As needed, participate in due diligence assessments of new product business opportunities.

Provide updates of franchise needs and forecasting resource demands to GCD management and clinical study teams.

Work closely with the CSM (clinical study management), data management group and biostatisticians from study design through to reporting of results.

Assist Clinical Study Managers as needed in training investigators, research coordinators, Contract Research Organizations (CROs), central laboratories, and other study vendors on

methodological study procedures. Support scientific and professional meetings consistent with franchise responsibility.

Identify and establish professional relationships with KOLs, potential study investigators and professional organizations to support Global Clinical Plan development and

maintenance.

Identify and implement process improvements by providing innovative and creative insights to department SOPs and policies.

Participate in internal/external GCD-related audits, and regulatory inspections as needed; Implement appropriate corrective and preventative actions (CAPA), if necessary

 

Requirements

Travel – Domestic Internationally up to 25

 

Education

Doctor’s degree or equivalent in science related/health field, or combination of equivalent education and experience in a medical or scientific setting. Additional training in methodology or clinical epidemiological approaches preferred.

 

Licenses/Certifications

Experience

 

Minimum 8 – 10 years of experience in pharmaceutical industry, clinical study methodology setting or scientific/research field required.

 

Competencies

Ability to handle complex projects, and demonstrates flexibility in managing changing priorities, strategic problem solving and judgment skills.

Trained to think strategically and experienced in clinical study methodology.

Advanced negotiation and written and verbal communication skills in English.

Advanced knowledge of industry standards and best practices in clinical data management, US Code of Federal Regulations, ISO 14155, ICH GCP.

 

Supervision

A supervisory position

 

Other

 

Experience with medical literature reviews and publication policies

Experience with Clinical Trial

Management Systems

Experience with Microsoft Access, Excel, Word, Powerpoint, Outlook, Sharepoint, Visio and Project

Experience with some statistical programs like SAS, STATA, R is beneficial

 

临床运营总监

工作职责:

1、负责统筹管理并组织实施临床研究项目,进行全面的质量控制与管理,督导按时完成项目的启动、实施及结题工作。

2、根据公司的统一部署,按照项目的级别调配团队资源,确保重大项目快速、高质量完成。

3、负责与药物临床研究相关的关键审评专家、临床专家和其他临床研究资源沟通和交流,协助制定正确的临床研究战略和方案,从而保障临床研究的顺利进行。

4、拓展并维护重点专家/医院资源,建立所需治疗领域的高水平专家团队。

5、负责团队的构建和培训管理体系,建立并定期完善临床运营相关的SOP。

任职要求:

1、专业背景要求:

(1)医学、药学、生物学等相关专业硕士及以上学历。

(2)大型制药企业8年以上药物临床研究实施经验,5年以上项目管理工作经验和团队管理经验。

2、能力要求:

(1)具备丰富的化药或生物药临床研究经验,精通临床研究全过程,熟悉国内外药物临床研究的法规政策,及临床研究发展与现状。

(2)负责过创新药或国际多中心临床研究项目者优先;熟悉肿瘤、内分泌、心血管、精神神经领域药物临床研究者优先。

(3)拥有丰富的行业资源,有能力对临床资源进行协调,并能及时协调解决临床研究中的各种问题。

(4)具有优秀的沟通协调能力、资源整合能力、策划能力及团队管理能力,具有较强的领导力、执行力、问题解决能力及应急预案管理能力。

3、语言要求:具备优秀的中文写作和表达能力,良好的英文文献阅读能力。

 

临床大区总监

工作职责:

1、高质量、高效率地领导负责区域内的临床运营工作,确保所有试验严格按照试验方案、公司SOP和法规进行。

2、负责区域内临床研究实施的全过程管理,把控试验质量与进度。

3、负责区域内相关疾病领域学术带头人和其他临床研究资源的建立及维护。

4、负责区域内监查团队的组织管理和团队建设工作,负责人员的培训以及绩效考评。

任职要求:

1、专业背景要求:

(1)医学、药学、生物学等相关专业硕士及以上学历。

(2)大中型制药企业5年以上药物临床研究实施经验,2年以上项目管理工作经验和团队管理经验。

2、能力要求:

(1)具备丰富的化药或生物药临床研究经验,熟悉临床研究全过程,熟悉国内外药物临床研究的法规政策,及临床研究发展与现状。

(2)负责过创新药或国际多中心临床项目者优先;熟悉肿瘤、内分泌、心血管、精神神经领域药物临床研究者优先。

(3)拥有丰富的行业资源,有能力对临床资源进行协调,并能及时协调解决临床研究中的各种问题。

(4)具有优秀的沟通协调、团队管理和执行能力。

3、语言要求:具备良好的中文写作和表达能力。

 

质量控制版块—质量控制负责人1人

工作职责:

1、统筹管理临床试验稽查工作,系统审阅稽查计划及报告,提炼共性管理措施。

2、建立临床试验质量体系、流程和制度,组织制定相关SOP,定期审阅及更新。                                                                                                                                                 3、负责临床稽查团队建设和临床稽查培训,负责团队的培养、管理与考核。

4、负责部门培训计划的制定和实施,确保临床研究培训有序开展。

任职要求:

1、学历要求:本科及以上学历。

2、专业要求:医学或药学相关专业。

3、工作经验:

(1)具备3年以上临床监查经验,3年以上临床稽查经验;

(2)具备3年以上质量管理或稽查管理经验;

(3)牵头负责过临床核查者,负责过创新药或国际多中心临床稽查者优先;

(4)熟悉肿瘤、内分泌、心血管、精神神经领域临床研究者优先。

4、能力要求:

(1)精通临床研究全过程,熟悉国内外临床研究的法规政策、临床研究发展与现状;

(2)具有丰富行业资源,能妥善处理临床质量管理中的各种问题;

(3)具有优秀的沟通协调、团队管理和执行管理能力。

5、职业素养:积极敬业、主动进取、责任感强、正直向上。

6、语言要求:具备优秀的中文写作和表达能力,良好的英文阅读能力。

 

⑪项目管理版块-项目管理总监1人

工作职责:

1、建立和完善临床试验项目管理体系、流程和制度,统筹规划项目管理计划,推动计划执行并确保进度和质量。

2、设置临床研究各阶段管理关键要素,负责临床各职能小组的协调,确保临床研究工作有序推进。

3、负责组织临床研究进度跟踪,更新管理要素并反馈,确保临床试验的节点把控。

4、分析评估项目的进程、财务及风险管理,剖析面临问题,制定针对性整改及预防措施。

5、负责项目管理团队建设和培训、指挥与管理。

任职要求:

1、学历要求:本科及以上学历。

2、专业要求:医学或药学相关专业。

3、工作经验:

(1)具备在CRO或制药企业5年以上药物临床研究实施经验,3年以上项目管理经验;

(2)负责过创新药或国际多中心临床项目者优先;

(3)熟悉肿瘤、内分泌、心血管、精神神经领域药物临床研究者优先。

4、能力要求:

(1)精通临床研究全过程,熟悉国内外药物临床研究的法规政策,及临床研究发展与现状;

(2)具有丰富行业资源,能应对临床研究项目管理中的各种问题;

(3)具有优秀的沟通协调、团队管理和执行管理能力。

5、职业素养:积极敬业、主动进取、责任感强、正直向上。

6、语言要求:具备优秀的中文写作和表达能力,良好的英文阅读能力。

 

⑫职位名称:临床负责人(Clinical Lead)

工作地点:美国

工作类型:全职

工作职责:

1、负责创新药物的临床研究方案设计,推动药物的早期临床研究顺利进行;

2、在创新药物的IND阶段,对临床前数据做出评估和反馈,组织相关内、外部讨论,决策IND方案及后续临床策略;

3、协助相关团队,确认药物与相关标准治疗方法之间的优势,推动临床前特征向临床结果的转化;

4、与临床专家及审评专家进行专业沟通,为早期临床研究设计提供科学和法规支持;

5、通过与相关团队的积极互动,为新的研究方向和新项目的研究提供临床医学知识和经验协助;

6、负责相应团队的培训和建设、指挥与管理。

任职要求:

1、学历要求:硕士或以上学历;

2、专业要求:兼具临床医学及药理研究背景;

3、工作经验:

(1)具有主治医生及以上资格,并具有硕士以上研究能力的肿瘤、内分泌、心血管、血液、神经疾病等内科专业医生;

(2)或临床医学等相关专业,在医疗机构承担过肿瘤、糖尿病、肝炎等疾病新药的I期临床方案设计,或在制药工业界/学术机构负责早期临床研发者优先;

4、能力要求:

(1)具有扎实的临床医学和临床药理学知识,对肿瘤、糖尿病、肝炎等疾病领域的早期临床研究有丰富的经验;

(2)具有对文献或研究结果进行综合分析、判断的能力;

(3)熟悉药物研发基本流程及相关政策法规的基本知识;

5、职业素养:积极敬业、主动进取、责任感强、正直向上;

6、语言要求:良好的中、英文阅读和写作能力。

 

Job Title: Clinical lead, US site

Job Location:

Job Type: Full-time

Job Description:

  1. In charge of protocol design and implementation for early stage drug development;
  2. Provide input to preclinical data during IND preparation via leading internal and external discussion and drive decision making regarding study protocol and sequential clinical strategy;
  3. Identify compounds’ strengths by cooperating with other functional teams in order to translate preclinical data to clinical output;
  4. Pursuing clinical and regulatory expertise externally to ensure protocol quality from clinical science and regulatory perspectives;
  5. Provide clinical expertise via interacting with other functional teams for selecting/deciding research direction or new project;
  6. Team management, training and etc.

 

Job Requirements:

  1. Master’s degree or above;
  2. Clinical medicine and pharmacology background;
  3. Work experiences:

(1) Physician-in-charge and Master’s degree in areas of tumor, endocrine, cardiovascular, blood, neurological diseases and etc.;

(2) Major in clinical medicine or other related professionals, has Phase I clinical protocol design experiences in tumor, diabetes hepatitis and other disease areas; or has experiences in early stage clinical development in pharmaceutical industry/academia in preferred;

  1. Qualifications:

(1) Strong knowledge background in clinical medicine and clinical pharmacology, and sufficient early stage clinical development experience in tumor, diabetes hepatitis and other disease;

(2) Ability to analyze and judge the literature and results of research;

(3) Familiar with the basic procedure of drug development and related policies and regulations;

  1. Professional accomplishment: Positive, Dedicated, initiative, responsible and rightful;
  2. Language skills: excellent Chinese and English skills in reading and writing

 

⑫Clinical Operation, lead.

 

Direct clinical monitoring operations for a designated Quintiles regional office or group to ensure projects are appropriately resourced and employees are trained and developed to meet project needs. Work with country/region leadership in formulating effective strategic goals and objectives for designated region and assures operational alignment with senior management priorities. Lead strategic initiatives work with other functional management to develop implementation plans. Supervise Clinical Research Specialist (CRSs), Clinical Operations’ Associate Directors and/or Managers.

 

RESPONSIBILITIES

 

  • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
  • Direct the hiring and selection process for a group of clinical staff by conducting candidate review through participation in the interviewing process. Establish methods to develop and evaluate office/region-based onboarding processes. Develop standard processes to ensure that staff has the proper materials, systems access and training to complete job responsibilities. Oversee the execution of the training plan, SOP review and mentored training experiences for a region/office/country.
  • Provide a leadership role in country/region clinical resourcing process through continual evaluation of existing and future resource alternatives, pro-active planning and collaboration with study team leadership and operational peers.
  • Evaluate the quality of the clinical work product for a variety of job roles and/or a specialized job function. Evaluate regional workload, quality and budget metrics through regular review and reporting of findings. Collaborate with senior management and other functional leadership to improve efficiencies, project outcomes and quality metrics for clinical projects.
  • Act as a coach and mentor for lower level staff as they develop in their role. Works collaboratively with project leadership including the PM, client representatives and other functional leadership to manage project related challenges and to achieve exemplary customer service.
  • Analyze and reviews budgets for clinical studies within region. Pro-actively plan for appropriate clinical operations budget consumption and guides line managers and CRSs in managing variances and in developing corrective fiscal action plans.
  • Conduct Clinical Project Review and participates in Project Management Review according to regional guidelines and interfaces with appropriate functional leadership to achieve positive outcomes.
  • Participate and may lead corporate or departmental quality or process improvement initiatives.
  • May act as a client liaison.

 

All responsibilities are essential to job functions unless noted as non-essential

Qualifications

 

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

 

  • Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Strong knowledge of clinical research financial parameters and project financial tracking and accounting methods
  • Strong leadership skills
  • Effective presentation skills
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
  • Strong written and verbal communication skills including good command of English
  • Excellent organizational and problem solving skills
  • Effective time management skills and ability to manage competing priorities
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

 

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in a health care or other scientific discipline or educational equivalent; 12 yrs of clinical trials experience including 7 years experience in a leadership capacity; or equivalent combination of education, training and experience”

 

PHYSICAL REQUIREMENTS

  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Regular sitting for extended periods of time
  • Frequent travel, approximately 30-40% of work week

 

EEO Minorities/Females/Protected Veterans/Disabled

 

Biologics

职位名称:生物大分子发现总监(Hybridoma)

工作地点:美国新泽西

工作类型:全职

岗位职责:
1. 负责单克隆抗体发现阶段的抗原类型选择,动物免疫方案的制定,杂交瘤的制备、评价和筛选;
2. 在创新单克隆抗体发现过程中,协同其他专业团队,保证项目快速高质量推进;
3. 协助调研临床疾病治疗需求,进行创新项目的选题立项;
4. 负责杂交瘤实验室仪器设备、试剂耗材等的综合管理;
5. 负责相应团队的培训和建设、指挥与管理。

岗位描述:
1. 学历要求:博士学历;
2. 专业要求:免疫学、分子生物学、细胞生物学等相关专业;
3. 工作经验:
1) 具有8年以上杂交瘤技术开发单克隆抗体工作经验;
2) 或具有5年以上国外药企杂交瘤部门的成功经验;
4. 能力要求:
1) 具有扎实的免疫学、分子生物学及杂交瘤背景知识,对抗体发现的最新研究进展能快速分析、判断、获取和应用;
2) 了解大分子药物研发基本流程及相关政策法规的基本知识;
3) 积极敬业、主动进取、责任感强、正直向上;
4) 具有团队管理能力;
5) 语言要求:良好的中英文阅读及写作能力。

 

②职位名称:生物大分子发现总监(Phage Display)

工作地点:美国新泽西

工作类型:全职
岗位职责:
1. 负责构建人抗体的噬菌体展示库,利用展示技术进行新单克隆抗体序列的筛选、鼠源抗体人源化、亲和力成熟以及抗体成药性的优化;
2. 负责除单克隆抗体外的其他新型结构抗体包括双特异抗体、单域抗体的噬菌体展示筛选、优化;
3. 在创新生物大分子药物的研发过程中,协同其他专业团队,保证项目研发快速高质量推进;
4. 协助调研临床疾病治疗需求,进行创新项目的选题立项;
5. 负责噬菌体展示实验室仪器设备、试剂耗材等的综合管理;
6. 负责相应团队的培训和建设、指挥与管理。

岗位描述:

1. 学历要求:博士学历;
2. 专业要求:分子生物学、生物化学、免疫学等相关专业;
3. 工作经验:
1) 具有8年以上噬菌体展示技术开发生物大分子药物工作经验者;
2) 或具有5年以上国际大药企的噬菌体展示筛选部门成功经验者;
4. 能力要求:
1) 具有扎实的分子生物学知识,对噬菌体展示技术(或其他展示技术)的最新研究进展能快速分析、判断、获取和应用;
2) 了解生物药物研发基本流程及相关政策法规的基本知识;
3) 积极敬业、主动进取、责任感强、正直向上;
4) 具有团队管理能力;
5) 语言要求:良好的中英文阅读及写作能力。

 

③职位名称:生物工艺总监(细胞工艺开发与放大)

工作地点:中国.成都

工作类型:全职

工作职责:

  1. 负责CHO哺乳动物细胞表达重组蛋白或抗体药物的培养工艺开发、放大、验证和技术转移,解决关键技术问题;
  2. 在生物大分子药物的研发过程中,衔接配合下游纯化、制剂、质量研究团队,推动项目的整体前进;
  3. 负责生物大分子药物临床以及生产申报的细胞培养工艺相关材料的准备及审核;
  4. 负责相应团队的培训和建设、指挥与管理;
  5. 负责细胞培养小试实验室和中试GMP车间的运行和管理,包括文件体系制定、实施,仪器设备的运行、维护,原材料、试剂耗材请购、管理,研究资料的汇总、分析、归档,保证项目的整体进度和质量。

任职要求:

  1. 学历要求:硕士或以上学历;
  2. 专业要求:生物工程、细胞生物学等相关专业,生物工程专业优先;
  3. 工作经验:

1)         具有8年以上哺乳动物细胞培养工艺开发、放大、验证以及转移工作经验者;

2)         或具有5年以上在国际大型制药企业从事哺乳动物细胞培养工艺开发经验;

  1. 能力要求:

1)         具有扎实的哺乳动物细胞培养工艺知识,对研究项目的相关工艺问题,具备快速分析、查阅文献和解决的能力;

2)         熟悉生物药物哺乳动物细胞培养相关的申报注册法规;

3)         积极敬业、主动进取、责任感强、正直向上;

4)         具有团队和实验室管理能力;

5)         语言要求:良好中英文阅读及写作能力。

 

④职位名称:生物工艺总监(培养基开发)

工作地点:中国.成都

工作类型:全职

工作职责:

1、负责公司无血清培养基配方的开发和优化,获得化学成分明确的培养基配方;

2、负责建立符合cGMP标准的工业化细胞培养基生产平台;

3、建立无血清培养基进入研发及生产部门的质量控制标准。

 

任职要求:

1、学历要求:博士学历。

2、专业要求:细胞生物学、生物工程、生物制药等相关专业;

3、工作经验:

(1)具有五年以上动物细胞培养基配方开发经验,并有培养基开发成功案例;

(2)具有干粉培养基生产经验;

(3)具备较强的细胞培养工艺开发经验;

(4)具有海外培养基开发公司工作经验的人员优先考虑;

4、能力要求:

(1)较高的生物医药专业水平,熟悉GMP,熟悉国内外培养基开发及生产法规;

(2)具有研发团队管理经验,能为研发人员提供指导和培训;

5、语言要求:良好的中、英文沟通及写作能力。

 

Job Title: Director of Biotechnology (Mammalian Cell Medium development)

Job Location: Chengdu Sichuan, China

Job Type: Full-time

Job Description:

  1. Being responsible for exploring and optimizing company’s serum-free media, defining composition of these chemical defined media, and validating their application in large-scale production of recombination proteins/antibodies;
  2. Being responsible for establishing cGMP-compliance platform for medium production in industrial scale;
  3. Establishing the standard system for quality control of serum-free media being used in the R & D and production departments.

 

Job Requirements:

  1. Ph.D. in cell biology, bio-engineering, bio-pharmaceutical and other related fields;
  2. Capable to communicate in Chinese (Mandarin);
  3. Working Experience:

(1) At least 5 years’ experience in the development and optimization of various media with successful and solid track records;

(2) Hands-on experience in the production of dry powder media at least in middle scale;

(3) Strong experiences on cell culture process development in biopharmaceutical area;

(4) Related experiences in oversea biotech companies preferred;

  1. Qualifications:

(1) Higher level of a biopharmaceutical expertise, being familiar with cGMP, familiar with and relevant regulations, both domestic and foreign abroad, on medium development and production regulations;

(2) With R&D team management experience, can provide guidance and training, both scientifically and technically, for to R&D personnel.

 

——————————————————————————————————

⑤职位名称:生物工艺总监(纯化工艺开发与放大)

工作地点:中国.成都

工作类型:全职

工作职责:

1、负责重组蛋白、抗体类药物的纯化工艺开发和放大;

2、建设并完善重组蛋白、抗体类药物纯化技术平台,管理纯化小试及中试实验室,参与生产车间设计和建设;

3、完成纯化培养相关的项目管理和申报,确保符合注册法规与未来趋势要求。

 

任职要求:

1、学历要求:硕士及以上学历;

2、专业要求:生物化学,化学工程,生物物理化学等相关专业;

3、工作经验:

(1)5年以上生物制药企业管理经验,具有丰富的蛋白质纯化工艺开发和放大经验;

(2)具有海外制药公司上述工作经验者优先考虑;

4、能力要求:

(1)熟悉全球生物药研发指导原则、药政法规以及相关临床申报要求;

(2)能够根据项目特点,制定详实研究方案、完成疑难方法的开发及问题的解决;

(3)具备良好的团队管理能力,能为研发、生产人员提供指导和培训;

(4)具备良好的规划和领导力,严谨求实的科研作风,良好的沟通表达协调能力好和责任心;

5、语言要求:良好的中、英文沟通及写作能力。

 

Job Title: Director of Biotechnology (Purification Process Development and Scale-up)

Job Location: Chengdu, China

Job Type: Full-time

Job Description:

  1. Process development and scale-up of recombinant protein/ antibody purification;
  2. Build-up and continuous optimization of recombinant protein, /antibody purification platform, management of pilot lab active participation in design and construction of manufacturing facility;
  3. Being responsible for managing relevant projects and documents on product purification in compliance with CFDA/FDA/EMA regulations.

 

Job Requirements:

  1. Education: Master Degree or above;
  2. Major: Biochemistry, Chemical Engineering, Biophysical Chemistry or related fields;
  3. Experience:

(1) 5+ years management experience in bio-pharmaceutical companies, skilled in process development and scale-up of protein purification;

(2) Hands-on relevant experience in overseas pharmaceutical company preferred;

  1. Qualifications:

(1) Familiar with FDA/CFDA regulations on biologics products at different stages;

(2) Strong capabilities in experiment design, project management and trouble-shooting with proven track records;

(3) Sophisticated skills on team management able to provide guidance and training for professional personnel with different functions and levels;

(4) Requirement for leadership and willing to take more responsibilities.

  1. Language: Good communication skills, both oral and writing, in English and Chinese.

 

 

⑥职位名称:大分子质量研究总监(Bioassay)

工作地点:中国.成都

工作类型:全职

工作职责:

  1. 负责生物大分子药物(包括单克隆抗体、重组蛋白、ADC药物)的质量研究工作,特别是细胞生物学活性检测(包括Cytotoxicity、ADCC、CDC、Immune-related assay等)的方法建立、优化、验证和转移;
  2. 负责生物大分子药物临床以及生产申报的质量研究相关材料准备和审核;
  3. 在生物大分子药物的开发过程中,协同其他专业团队,推动项目的整理前进;
  4. 负责Bioassay实验室的综合管理,包括文件体系制定、实施,仪器设备的运行、维护,试剂耗材请购、管理,研究资料的汇总、分析、归档,保证项目研究的整体进度和质量;
  5. 负责相应团队的培训和建设、指挥与管理。

任职要求:

  1. 学历要求:硕士或以上学历;
  2. 专业要求:细胞生物学、药学、生物化学等相关专业;
  3. 工作经验:

1)         具有5年以上大分子药物生物学活性检测及相关注册申报工作经验者;

2)         具有在国际大型制药企业从事生物学活性检测经验者优先;

  1. 能力要求:

1)     具有扎实的细胞生物学、生物化学知识;对研究药物所治疗的相关疾病,具备快速分析、探索和建立生物活性检测方法的能力;

2)         熟悉生物药物质量研究,特别是bioassay方面,相关的注册申报法规;

3)         积极敬业、主动进取、责任感强、正直向上;

4)         具有团队和实验室管理能力;

5)         语言要求:良好的沟通及写作能力。

 

⑦职位名称:生物药物生产执行总监

工作地点:中国.成都

工作类型:全职

工作职责:

1、负责生物药生产的全面管理,包括2000L规模细胞培养车间、纯化车间和制剂车间(负责3期临床样品的生产,生产申报及获批后的上市生产);

2、建设和完善车间岗位设置、人员配备及排班制度,解决大规模原液及制剂生产过程中的问题;

3、车间建成前期带领团队开展委托生产服务(CMO),承担后续生产线建设相关工作内容。

 

任职要求:

1、学历要求:硕士及以上学位;

2、专业要求:细胞生物学、生物工程、生物制药等相关专业;

3、工作经验:

(1)5年以上生物药GMP生产车间管理经验;

(2)负责过生物药生产申报工作,并获得上市许可,具有车间建设筹建经验;

(3)具有大型制药企业工作经验;

4、能力要求:

(1)熟悉全球生物药生产规范及生产申报法规要求;

(2)熟悉生物制品原液及制剂生产工艺流程,熟悉生物制品原液及制剂生产车间的管理和运行;

5、职业素养:具有高度的责任感和敬业精神。

6、语言要求:良好的中、英文沟通及写作能力。

 

Job Title: Production Executive Director

Job Location: Chengdu Sichuan, China

Job Status: Full-time

Job Description:

  1. Handle overall company’s manufacturing activities, including one cell culture plant, one purification plant and one formulation plant(responsible for the manufacture of phaseⅢclinical grade biopharmaceuticals, BLA filing, manufacture of post-marketing product);
  2. Optimize the job responsibilities of staff team, as a trouble-shooting for the manufactory process;
  3. Operate the CMO service, responsible for the new plant construction in the future.

 

Job Requirements:

  1. Education: Master’s degree or above in cell biology, bio-engineering, bio-pharmaceutical and other related fields;
  2. Language: capable to communicate in Chinese (Mandarin);
  3. Working Experience:

(1) At least 5 years’ experience in manufacture management;

(2) Responsible for BLA filing and have been approval, Prior experience in building manufacturing plants;

(3) Prior experience in famous companys.

  1. Qualifications:

(1) Familiar with the global biologics BLA, FDA/CFDA regulations,

(2) Familiar with large-scale mammalian cell culture, purification, formulation and plant management,

(3) Highly accountable.

 

⑧职位名称:生物药物细胞培养生产总监

工作地点:中国•成都

工作类型:全职

工作职责:

1、负责生产规模工艺转移、放大,解决关键技术问题,确保生产线顺利运行;

2、负责生产车间建设以及生产文件体系建立;

3、负责细胞培养生产过程的工艺控制与改进;生产数据的回顾与分析;

4、负责按照GMP要求和公司流程,进行内部审计、偏差调查,制定预防纠偏措施并监督各项行动的执行情况。

任职要求:

1、学历要求:本科及以上学历;

2、专业要求:细胞生物学、生物工程、生物制药等相关专业;

3、工作经验:

(1)5年以上哺乳动物细胞大规模培养生产经验;

(2)具有2000L及以上规模的细胞培养生产经验,具有申报生产或GMP核查经验;

(3)有海外制药公司上述工作经验者优先考虑;

4、能力要求:

(1)熟悉重组蛋白质药物GMP车间的设计、管理和运行;

(2)熟悉CHO细胞表达产品的生产或质量管理,熟悉国内外GMP法规;

(3)具有生产团队管理经验;

5、具有高度的企业忠诚度、责任感和敬业精神;

6、语言要求:良好的中、英文沟通及写作能力。

 

Job Title: Director, Biologics Process Development (Plant Large-Scale Production by Mammalian Cell Culture)

Job Location: Chengdu Sichuan, China

Job Type: Full-time

Job Description:

  1. Responsible for the scale-up, technical transfer scale of to large-scale production process transfer, scale-up, to solve the key technical problems, to ensure the production line running smoothly;
  2. Responsible for the construction of the workshop and the establishment of the production document system;
  3. Responsible for the cell culture production process control and continues improvement; production data review and analysis;
  4. Responsible for conducting cGMP requirements and all internal processes and large-scale production in compliance with cGMP requirements, leading or participating in internal audits, deviation surveys, developing corrective measures to correct and monitoring the implementation of actions.

 

Job Requirements:

  1. Education: Bachelor degree or above in cell biology, bio-engineering, bio-pharmaceutical and other related fields;
  2. Language: capable to communicate in Chinese (Mandarin);
  3. Working Experience:

(1) At least 5 years’ experience in large scale mammalian cell culture production;

(2) Experience in cell culture with 2000L Bioreactors and above, with hands-on experience in production or cGMP verification;

(3) Oversea industry experience preferred;

  1. Qualifications:

(1) Familiar with recombinant protein drugs’ and hands-on experiences on cGMP plant design, management and operation;

(2) Familiar with CHO cell product and hands-on experience on large-scale production of recombinant proteins/antibodies by CHO cells, or quality management experience, familiar with domestic and foreign GMP regulations;

(3) Experience in production team management; high degree of loyalty, responsibility and professionalism.

 

⑨职位名称:生物药物纯化生产总监

工作地点:中国•成都

工作类型:全职

工作职责:

1、负责建立纯化生产平台,组建纯化生产团队,并对部门员工进行技能等相关培训;

2、负责纯化工艺转移、工艺放大、验证等相关工作;解决生产的技术问题;

3、负责生产车间设计与建设;

4、负责车间厂房设施、设备验证及再验证;

5、负责生产车间所需管理文件和技术文件的审核;

6、负责编制年度生产计划、进行生产调度、管理和控制;

7、协助完成产品质量年度回顾。

任职要求:

1、学历要求:本科及以上学历;

2、专业要求:生物工程、制药工程、生物化学或相关专业;

3、工作经验:

(1)具备真核/原核表达产物纯化生产建设和管理经验,其中具备5年以上GMP纯化生产管理经验和2000L以上(动物细胞培养)规模纯化生产经验;

(2)具备车间建设、生产现场核查、GMP认证经验者优先;

(3)具备国外工作经历或外资企业工作经历者优先;

4、能力要求:

(1)熟悉GMP生产车间所需管理文件和技术文件起草、审核和工艺优化、验证等工作能力;

(2)具备有较强的分析问题、解决问题能力,能够快速把握问题关键点并提供行之有效的技术方案;

(3)熟悉国内外GMP法规,能够严格按照GMP相关要求开展工作;

5、工作态度端正,作风严谨,责任心强,沟通能力强;

6、语言要求:良好的中、英文沟通及写作能力。

 

Job Title: Director of Biotechnology (Large Scale Purification)

Job Location: Chengdu, China

Job Type: Full-time

Job Description:

  1. Responsible for build-up of the production team and technical platforms protein purification with routine staff training;
  2. Responsible for technical transfer on purification process scale-up and validation;
  3. Responsible for design and construction of manufacturing facility;
  4. Responsible for installation, validation and operation of the facility and equipment;
  5. Audit management and technical documentation for product production;
  6. Make annual production plan, manage and execute production schedule;
  7. Responsible for annual review of product quality.

 

Job Requirements:

  1. Education: Bachelor Degree or above;
  2. Major: biological engineering, pharmaceutical engineering, biochemistry or related;
  3. Experience:

(1) Sophisticated experience in the production and management of eukaryotic / prokaryotic expression product purification, including 5+ years management experience in cGMP purification and 2000L scale or above (animal cell culture) production;

(2) First-hand experience in facility construction, validation/inspection of production site, with cGMP certification preferred;

(3) Working experience in overseas pharmaceutical company preferred;

  1. Qualifications:

(1) Solid skill in drafting and auditing GMP facility documents, both managerial and technical; sophisticated experiences in process optimization, validation;

(2) Strong skills in trouble-shooting, capability in provide technical solution, timely and completely;

(3) Familiar with CFDA/FDA/EMA regulation in compliance with CGMP standards during production period for biologics production;

  1. Rigorous working attitude, profound inter-personal skills, strong sense of responsibility;
  2. Language: Good communication and writing skills in both English and Chinese.

 

⑩职位名称:生物药物制剂生产总监

工作地点:中国.成都

工作类型:全职

工作职责:

  1. 负责生物药物制剂生产工艺放大、转移和验证,产品外包材的选择和确定,以及日常的制剂生产管理;
  2. 负责制剂生产工艺的监控,并反馈制剂工艺开发团队;
  3. 负责新的制剂生产技术的引进与实施;
  4. 参与制剂生产车间的设计与建设;
  5. 参与制剂生产团队的组建与管理。

任职要求:

  1. 学历要求:本科或以上学历;
  2. 专业要求: 制药工程、 药剂学、生物工程或相关专业;
  3. 工作经验:

1)         具有5年以上国内外生物药物制剂GMP生产管理工作经验(包括液体和冻干制剂);

2)         具有生物制剂车间建设,或国外生物制药企业制剂生产工作经验者优先;

  1. 能力要求:

1)         熟悉生物药物液体和冻干制剂生产过程,以及国内外先进的制剂技术;

2)         熟悉生物药物国内外GMP法规;

3)         积极敬业、主动进取、责任感强、正直向上;

4)         具有团队协调和管理能力;

5)         语言要求:良好的沟通与写作能力。

 

⑪职位名称:生物药物生产质量管理总监

工作地点:中国.成都

工作类型:全职

工作职责:

1、负责组建生物药物(包括治疗性单克隆抗体、双特异性抗体、ADC、融合蛋白等)QA团队,负责QA团队的日常管理;

2、负责建立、维护并持续改进质量保证体系,确保公司质量体系持续高效运行;

3、组织实施公司内部质量管理体系自检,定期检查评估质量管理体系的适用性和有效性,组织公司各类GMP认证(国内及国际)工作;

4、组织接受第三方审计单位及客户(如委托生产方)质量审计;

5、组织物料供应商评估及审计,组织QA团队建立及维护合格供应商清单;

6、协助新建厂房及生产线的设计与建设工作,确保厂房设施、设备符合GMP相关法规要求;

7、组织与协调确认与验证工作;

8、组织建立公司质量体系文件管理系统,指导各部门人员编制质量管理体系文件,确保文件经过必要的审批,采取有效措施确保体系文件严格、有效执行;

9、组织与质量相关的培训工作,采取适当措施确保培训效果;

10、负责偏差、变更、CAPA的评估与审核;

11、协助VP开展质量类投诉的调查与处理;

12、负责产品质量回顾分析,组织完成年度质量回顾分析报告。

 

任职要求:

1、学历要求:本科及以上学历(硕士及以上学历更佳);

2、专业要求:药学、生物工程、制药工程、生物化学或相关专业。

3、工作经验:

(1)具备5年以上生物药物产品质量管理工作经验;

(2)具备车间建设、生产现场核查、GMP认证(美国或欧盟认证)经验;

(3)具有领导团队建立质量管理体系或质量保证体系经验;

(4)具有欧美国家质量负责人(VP)工作经历者优先;

4、能力要求:

(1)熟悉国家有关药品管理的法律法规、熟悉国内外GMP法规;

(2)具备较强的前瞻性和预见性,能够提前对潜在风险提出预案;能够为较为复杂的团队编制有效的、合理的工作计划;

(3)思维缜密,善于分析复杂问题的多种可能原因,恰当运用已有知识、技术等多种手段,权衡方案优劣,找出切实可行的解决办法;

5、职业素养:工作态度端正,作风严谨,有原则性,责任心强,沟通能力强和管理能力强;

6、语言要求:良好的中、英文沟通及写作能力。

 

Job Title: Biologics QA Director

Job Location: Chengdu, China

Job Type: Full-time

Job Description:

  1. Responsible for building of QA team of biologics (including therapeutic monoclonal antibodies, bispecific antibodies, ADC, fusion protein, etc.), and for the daily management of QA team;
  2. Responsible for establishing, maintaining and continuously improving the quality assurance system to ensure that the company’s quality system functions efficiently;
  3. Responsible for organizing and implementing the company’s internal quality management system including self-testing, regular auditing and assessing of applicability and effectiveness of the quality management system, and for organizing various types of company GMP certification (domestic and international);
  4. Responsible for coordinating quality audit by the third-party audit department and customers (e.g. entrusting party);
  5. To assess and audit material suppliers, and to establish and maintain a list of qualified suppliers;
  6. To assist in the design and construction of new plant and production lines, and ensure that plant facilities and equipment comply with GMP regulations;
  7. To organizing and coordinating validation and verification;
  8. To establish the company’s management system for quality control, to guide the staff to prepare the quality management system documents, to ensure that the documents through necessary approvals, and take effective measures to ensure that the system documents be implemented strictly and effectively;
  9. Responsible for organizing quality-related training and taking appropriate measures to ensure training effectiveness;
  10. Responsible for deviation, change, CAPA assessment and review;
  11. To assist VP in the investigation and handling of quality complaints;
  12. Responsible for product quality review analysis, organizing to provide annual quality review analysis report.

 

Job Requirements:

  1. Education: Bachelor degree or above (Master or above is preferred) is required in Pharmacy, bioengineering, pharmaceutical engineering, biochemistry or related fields;
  2. Language: Capable of communication in English or Mandarin Chinese;
  3. Experience:

(1) At least 5 years experience in quality management of biopharmaceutical products;

(2) Experience in Workshop construction, production site verification, GMP certification (US or EU certification);

(3) Experience in organizing a team to build a quality management system or quality assurance system;

(4) Experience in Quality Management (VP) in Europe and the United States is preferred;

  1. Qualifications:

(1) Familiar with the drug administration laws and regulations, and GMP regulations (domestic and international);

(2) Strong forward-looking and predictability, able to plan ahead of the potential risk, and prepare effective and reasonable work plan to the more complex team;

(3) Able to think clearly and sensibly, good at analytical and problem solving skills;

(4) Highly accountable.

 

 

⑫职位名称:生物药物生产QC总监

工作地点:中国•成都

工作类型:全职

工作职责:

1、负责组建生物药物(包括治疗性单克隆抗体、双特异性抗体、ADC、融合蛋白等)QC团队,管理和指导质量控制部门的工作,确保公司的GMP质量控制系统符合国内外制药行业法规的要求;

2、建立生物药物质量控制平台及相应的文件体系,负责QC相关质量文件的编写指导/起草/审核/批准;

3、组织、指导分析方法的建立、验证及转移,确保这些过程符合国内外制药行业法规的要求;

4、负责组织及执行QC相关培训及考核工作,提高QC团队的专业知识水平及技能。

 

任职要求:

1、学历要求:本科及以上学历(硕士及以上学历更佳);

2、专业要求:药学、生物工程、制药工程、分析化学、生物化学或相关专业;

3、工作经验:

(1)具备5年以上国外GMP生物制药企业的相关工作经验及管理工作经验;

(2)具有QC实验室建设、研制现场核查、GMP认证(美国或欧盟认证)经验;

(3)具有领导团队建立质量控制系统的经验;

4、能力要求:

(1)熟悉国内外生物药品质量控制的相应政策和法律法规;

(2)熟悉生物药品质量控制的相应的仪器应用,方法开发和验证;

(3)思维缜密,善于分析复杂问题的多种可能原因,恰当的运用已有知识、技术等多种手段,权衡方案优劣,找出切实可行的解决办法;

(4)工作态度端正,作风严谨,有原则性,责任心强,沟通能力强和管理能力强;

5、语言要求:良好的中、英文沟通及写作能力。

 

Job Title:QC Supervisor for Biologics Production

Job Location:Chengdu, China.

Job Type: Full-time

Job Description:

  1. To be responsible for building a QC team of biologics (including therapeutic monoclonal antibodies, bispecific antibodies, ADC, fusion protein, etc.), for heading and administering quality control departments. To ensure that the company’s QC system fulfills the requirements of domestic and international pharmaceutical industry regulations;
  2. To establish a biologics quality control platform and the corresponding documents system and to be responsible for the compilation guidance / drafting / review / approval of QC-related quality documents;
  3. To organize and guide the establishment, validation and transfer of the analytical methods and to ensure they fulfill the requirements of domestic and international pharmaceutical industry regulations;
  4. To be responsible for the organization and implementation of the QC related training and test to improve the professional knowledge level and skills of QC team members.

 

Job Requirements:

  1. Education required: College degree and above(Master or above is preferred);
  2. Major requirements: Pharmacy, bioengineering, pharmaceutical engineering, analytical chemistry, biochemistry or related majors;
  3. Working Experience:

(1) At least 5 years management or relevant work experience in foreign GMP biopharmaceutical enterprises;

(2) Experienced in QC laboratory construction, research on-site verification, GMP certificate (EU or US certificate);

(3) Experienced in leading a team and building a quality control system;

  1. Qualifications:

(1) To be familiar with domestic and foreign policies, laws and regulations about biologics quality control;

(2) To be familiar with the equipment application, method development and validation of biological medicine quality control;

(3) To be able to think clearly and sensibly, good at analytical and problem solving skills;

(4) To be rigorous style, and to have a correct work attitude, a strong sense of responsibility, a strong communication skills and a strong management ability;

  1. Language: Capable of communication in English and Chinese.

 

⑬职位名称:生物药物发酵工艺总监

工作地点:中国•成都

工作类型:全职

工作职责:

1、负责抗生素、多肽、蛋白类产品工艺开发、放大及生产,解决关键技术问题;

2、负责项目管理和申报,确保符合注册法规与未来趋势要求;

3、负责按照GMP要求建立生产文件体系,对生产过程工艺进行控制与改进,确保生产线顺利运行。

 

任职要求:

1、学历要求:本科及以上学历;

2、专业要求:发酵工程、生物工程、细胞生物学、生物制药等相关专业;

3、工作经验:

(1)5年以上原核或酵母菌株筛选与优化、发酵工艺开发经验;

(2)负责过中试或者生产规模的发酵工艺研究,完成IND或生产申报;

(3)有海外制药公司上述工作经验者优先考虑;

4、能力要求:

(1)熟悉全球生物药研发指导原则、药政法规以及相关临床申报要求;

(2)精通原核或酵母发酵工艺研究和工业化生产流程和技术;

(3)熟悉抗生素、多肽、蛋白类药物GMP车间的设计、管理和运行;

(4)   具有研发团队管理经验,能为研发人员提供指导和培训;

(5)具有高度的责任感和敬业精神;

5、语言要求:良好的中、英文沟通及写作能力。

 

Job Title: Director, microbial fermentation

Job Location: Chengdu, China

Job Type:  Full-time

Job Description:

  1. Responsible for the development, scale-up and production of antibiotics, peptides and protein products, to solve key technical problems;
  2. Responsible for project management and IND application, to ensure compliance with regulatory requirements and future trends;
  3. Responsible for the establishment of production documents in accordance with the requirements of cGMP system, responsible for the production process control and improvement in production to ensure the smooth operation of the production line.

 

Job Requirements:

  1. Education: Bachelor degree or above in Fermentation Engineering, bio-engineering, cell biology, bio-pharmaceutical and other related fields;
  2. Language: capable to communicate in Chinese (Mandarin);
  3. Working Experience:

(1) At least 5 years’ experience in Prokaryotic or yeast microbial screening, optimization and fermentation process development;

(2) Responsible for pilot or production-scale fermentation process research in pilot or production-scale, completing IND filing or production applications;

(3) Oversea industry experience preferred;

  1. Qualifications:

(1) Familiar with the global biologics R & D, EMA/FDA/CFDA regulations, and relevant clinical submission requirements;

(2) Proficient in prokaryotic or yeast fermentation process research and industrial production processes and technologies;

(3) Familiar with antibiotics, peptides, protein drugs GMP workshop design, management and operation;

(4) Managerial and leadership experience in building and developing R & D team;

(5) Capable to provide coaching and mentorship;

  1. High degree of loyalty, responsibility and professionalism.

 

微生物菌株开发总监(2名)

1、工作地点:成都

2、工作职责:

  • 负责菌株改造上游技术平台的搭建和开发:抗生素(包括中间体)、生物活化酶等生产工程菌的构建或遗传改造,通过基因工程、代谢工程等手段,构建、驯化、筛选获得适于工业化生产的工程菌株;
  • 负责新产品的评估立项及开发;
  • 指导解决项目实施过程中的关键技术难题,完成生产技术转移;
  • 负责团队培训、考核及管理工作。

3、任职要求:

  • 微生物学、生物化学或分子生物学等相关专业,本科及以上学历(至少5年以上相关工作经历);
  • 具备扎实的基因工程菌表达系统(大肠杆菌、酵母、丝状真菌、放线菌和其他野生菌株)的构建或遗传代谢改造经验,熟悉当前技术前沿方向和工业界的使用现状;
  • 具有(但不限于)硫氰酸红霉素、青霉素、头孢菌素C等抗生素,代谢改造相关项目经验者优先;
  • 熟悉产品评估立项和未来市场预测者优先;
  • 从事过研发团队管理工作者优先。

 

⑮细胞治疗总监

1、工作职责

  • 负责CAR-T细胞治疗技术平台的搭建和人员招聘;
  • 领导团队进行CAR-T细胞治疗的立项和项目推进;
  • 指导、解决项目实施过程中的关键技术难题;
  • 负责细胞治疗对外合作与商务谈判。

2、任职要求

  • 学历要求:博士;
  • 专业要求:生物、医学、药学等相关专业;
  • 工作经验:国内外药企3年以上CAR-T细胞治疗相关工作经验;
  • 能力要求:在CAR-T细胞治疗研发方面具有较丰富的经验;熟悉CAR-T制备、工艺优化、活性分析与质量控制等研发流程;从事过研发团队管理工作者优先考虑;有国外药企工作经验者优先考虑;
  • 语言要求:具备良好的英文读写和交流能力。

 

 

 Formulation

职位名称:口服固体制剂技术总监

工作地点:中国.成都/天津/苏州

工作类型:全职

工作职责:

1、负责口服固体制剂项目制剂研究:研究方案审核与修订、研究结果评价与审核、包括缓控释制剂);

2、负责口服固体制剂项目的管理:研究项目进度管控、资源调配、保证研究申报资料符合申报注册法规要求;

3、负责口服固体制剂的系统研究,构建技术平台;

4、负责相关技术、资源、人才和项目的评估与引进;

5、负责相应团队的培训、建设及管理。

 

任职要求:

1、学历要求:硕士及以上学历;
2、专业要求:药物制剂等相关专业;
3、工作经验:

(1)在国内外大型制药企业从事口服固体制剂研究10年以上;

(2)成功主持多项口服仿制药的开发;

(3)有在海外制药公司从业经验者优先考虑;
4、能力要求:

(1)熟悉口服固体制剂研究工艺,具有很强的分析及解决工艺问题的能力,熟悉产品的质量要求;

(2)熟悉国际(包括ICH,FDA和EMA)研发技术要求及国内药品技术审评要求和新药注册的相关法规;

(3)熟悉制剂产品体内外评价方法及要求,能够根据产品的药学特性及体内药代行为等对BE风险进行合理评估分析,并指导制剂研究工作,有效提高BE试验成功率;

(4)熟悉口服固体制剂研发和生产所用设备的原理、性能和质量要求;

(5)优秀的团队管理和执行管理能力,能为研发人员提供指导和培训;

5、职业素养:积极敬业、主动进取、责任心强、正直向上;

6、语言要求:有良好的沟通及写作能力。

 

Job Title: Director of Generics Formulation Development- Solid Oral Products

Job Location: Chengdu/Tianjin/Suzhou, China

Job Type: Full-time

Job Description:

  1. Accountable for formulation development of oral solid dosage forms, including reviewing and revising development strategy and plans, evaluating research results, writing and approving submission documents, and solving key technical issues during development of drug products (mainly generic products including sustained and controlled release dosage forms);
  2. Managing projects, including managing progresses of projects, resource planning and allocation, and ensuring compliance of submission documents with relevant China FDA filing regulations;
  3. Responsible for building development systems for oral solid products, establishing technology platforms;
  4. Evaluating outside technologies, resources, talents and drug development opportunities for internalization;
  5. Responsible for building, managing and training development teams.

 

Job Requirements:

  1. Education: Ph. D. or Master’s Degree in pharmaceutical sciences or related fields;
  2. 10+ Years of industrial experience in formulation and process development of oral solid products in large pharmaceutical companies (in China or other countries);
  3. Working experience in overseas companies is preferred:

(1) Familiar with the manufacturing processes, highly capable of solving process issues, and familiar with the quality requirements of oral solid dosage forms;

(2) Familiar with international technical requirements of drug product development (including ICH, US FDA and EMA) and China FDA requirements of technical review and regulations of drug product applications;

(3) Highly knowledgeable of in vitro and in vivo evaluation methods and requirements of formulation dosage forms, capable of assessing risks of BE studies based on the pharmaceutics characteristics and pharmacokinetics performance of dosage forms and directing formulation development for improving successful rate of BE studies;

(4) Familiar with the development and production scale equipment systems of oral solid dosage forms, including their working principles, capabilities and quality requirements;

(5) Highly experienced in team management and has strong execution capability; capable of coaching and training development teams;

  1. Has a positive and can-do attitude, highly self-driven, reliable, and honest;
  2. Language requirements: Chinese language (preferred) / English, has excellent communication and writing skills.

 

职位名称:注射剂研究技术总监

工作地点:中国·成都/天津/苏州

工作类型:全职

工作职责:

1、负责注射剂处方工艺研究方案的制定、注射剂项目研究的质量与进度、技术资料的审核等全过程管理;

2、在注射剂项目的研究过程中,负责工艺技术的生产转移,并协同其他专业团队或部门,推进药物的临床研究及上市生产;

3、通过对国内外注射剂产品信息搜集和调研,协同其它部门进行新项目的选题立项;

4、负责相应团队的培训、建设及管理。

 

任职要求:

1、学历要求:本科及以上学历;

2、专业要求:药物制剂等相关专业;

3、工作经验:

(1)国内外大型制药企业从事注射剂(含输液、水针、冻干粉针)研究10年以上,成功主持多项产品的仿制药开发;

(2)具有丰富的输液研究经验者优先;

(3)有海外制药公司从业经验者优先;

4、能力要求:

(1)熟悉注射剂处方工艺研究和工业化生产/验证的流程和技术,具有解决注射剂生产工艺和产品关键质量问题的能力;

(2)熟悉国际(包括ICH,FDA和EMA)研发技术要求,国内药品技术审评要求及药品注册的相关法规;

(3)积极敬业、主动进取、责任心强、正直向上;

5、语言要求:良好的沟通和写作能力。

 

Job Title: Director of Generics Formulation Development- Injectables

Job Location: Chengdu/Tianjin/Suzhou, China

Job Type: Full-time

Job Description:

  1. Responsible for managing the complete process of injectable formulations and manufacturing processes, including making strategies and plans of formulation and processes development; managing the quality requirements and project progresses, reviewing and approving technical documents;
  2. Managing injectable project technology transfer to production site; coordinating with other functions to facilitate clinical studies, commercial production and product launch;
  3. Searching and evaluating information of injectable products in the Chinese market and international markets, collaborating with other functions to establish new product development projects;
  4. Responsible for development team building, training and management.

 

Job Requirements:

  1. Education: a B.S. or higher degree in pharmaceutics or related disciplines;
  2. 10+ Years of industrial experience in parenteral formulation and process development (IV infusions, water injections, frozen powder injections) in large pharmaceutical companies, and has successfully developed multiple generic formulation products;
  3. Experience in infusion product development is preferred:

(1) Familiar with injectable formulation and process development, process validation and commercial production, capable of solving key manufacturing process and product quality problems;

(2) Familiar with international technical requirements of drug product development (including ICH, US FDA and EMA) and China FDA requirements of technical review and regulations of drug product applications;

  1. Has a positive and can-do attitude, highly self-driven, reliable, and honest;
  2. Language requirements: Chinese language (preferred) / English, has excellent communication and writing skills.

 

创新药物制剂总监

工作地点:中国·成都

工作类型:全职

工作职责:

  • 主持创新药物制剂开发工作,保证研究的系统性和规范性;
  • 负责剂型设计,制定制剂研发方案及计划,把控制剂研究进度,解决项目中的关键技术问题;
  • 与相关团队协作,从制剂角度对选题立项、分子设计及临床前研究等提供必要的技术支持及建议,推动药物的成药性研究和临床研究顺利进行,降低创新药物研发风险;
  • 指导中英文申报资料的撰写和审核;
  • 负责相应团队的培训和建设、指挥与管理。

任职要求:

  • 学历要求:硕士或以上学历。
  • 专业要求:药物制剂及相关专业。
  • 工作经验和能力要求:
  • 在国内外知名制药企业从事制剂研发工作5年以上;
  • 主持或参与3个以上1类新药制剂开发工作,有各种类型制剂研发经验者,或有成功的1.1类新药获批经验者优先;
  • 具有按照QbD理念进行制剂处方工艺开发经验者优先;
  • 熟悉药品注册的相关法规及技术审评要求;
  • 具有扎实的制剂技术及工艺知识,具有极强的解决制剂研发关键技术问题的能力;
  • 熟悉药物制剂处方筛选、工艺优化及工业化生产的流程和技术,熟悉新药开发不同阶段的制剂产品质量要求。
  • 职业素养:积极敬业、主动进取、责任感强、正直向上。
  • 语言要求:
  • 良好的英文阅读、中文沟通及写作能力;
  • 能熟练使用英语与他人交流。

 

Director of Formulation Development

Job Location:Chengdu, China

Job Type:Full Time

Job Description

  1. Lead Drug Product Formulation Development. Responsible for strategic planning, coordinating, and execution of the drug product formulation development / characterization activities.
  2. Determine and design dosage forms of drug candidate based on projected future clinical use, physicochemical properties, IP and other relevant date.
  3. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  4. Interact closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements.
  5. Writing and reviewing relevant reports for IND applications.
  6. Responsible for training, managing, and leading project teams.

Job Requirement Competencies:

  1. PhD in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and a minimum of 8 year experience in a development environment.
  2. 3+ year experience in leading small molecule formulation development with demonstrated successful IND application filing.
  3. Experience in leading with multiple phases of product development is highly desirable.
  4. Excellent communication skills (oral, written, presentation) and strong project management and demonstrated problem solving skills.
  5. Good knowledge of GMPs, CMC authorization, regulatory audit and inspection experiences are preferred. Familiar with government regulations, CFDA/FDA CMC Guidance Documents will be an advantage.
  6. Ability to work in a fast-paced, dynamic, environment.
  7. Strong project and team leading skills.
  8. Good Chinese and English language skills are essential.

 

 

职位名称:新型给药系统总监

工作地点:中国·成都

工作类型:全职

工作职责:

  1. 负责给药系统项目(重点在脂质体、纳米粒等纳米制剂)研究方案制定、研究的质量与进度、申报资料把关等研究实施的全过程管理;
  2. 负责解决项目推进过程中的关键技术问题,快速推进项目;
  3. 负责给药系统项目相关技术、资源、人才和项目的评估、引进;
  4. 搜集临床疾病治疗需求,结合DDS技术进行DDS新项目的选题立项;
  5. 负责给药系统项目全局发展战略和方向,DDS团队的培训和建设、指挥与管理。

 

任职要求

1、学历要求:硕士以上学历 (具有DDS产品产业化经验不受学历限制);

2、专业要求:药剂学及相关专业;

3、工作经验和能力要求:

(1)工作经验:

1)具有8年以上大型制药企业从事新型给药技术(重点在脂质体、纳米粒等)的实验室研发和工业化转化研究工作经验,成功研制3 个以上给药系统产品(包括进入申报注册、临床阶段);

2)在国外制药公司从事相关工作的人员优先;

3)具有研发DDS产品申报美国FDA的经验者优先;

(2)能力要求:

1)掌握国际(包括ICH,FDA和EMA)研发技术要求、国家药品技术审评要求及药品注册的相关法规;

2)掌握制剂研究工艺和工业化生产的流程和技术,具有很强的解决NDDS类产品制剂生产工艺(尤其是生产放大和技术转移)问题的能力,熟悉产品的质量要求;

3) 具有按照QbD理念要求进行制剂处方工艺研究的经历,熟悉诸如DOE、风险分析和控制、工艺放大、变更控制、技术转移、验证等要求;

4)较强的项目管理和团队管理能力,能为研发人员提供指导和培训;非常熟悉全球新型制剂发展现状及方向,具有前瞻性眼光;

4、语言要求:良好的中、英文沟通及写作能力。

 

Job Title: Director of NDDS

Job Location: Chengdu, China

Job Type: Full-time

Job Description:

  1. Responsible for management of NDDS projects (focusing on liposomes, nanoparticles and other nano preparations), including the development of research programs, the supervision of progress, checking the submission materials and so on;
  2. Focus on solving the key technology issues in the project development, advancing the project rapidly;
  3. Responsible for the assessment and introduction of new DDS technology, resources, talents and projects;
  4. Collect the unmet needs of clinical disease, select new DDS projects based on DDS technology;
  5. Responsible for the NDDS overall development strategy and direction, the training and construction, management of the DDS team.

 

Job Requirements:

  1. Education:Master degree or above;
  2. Profession:Pharmaceutical and related majors;
  3. Work Experience and Ability Requirements:

(1) Work Experience:

1) More than 8 years experience of R&D in large pharmaceutical companies (focusing on liposomes, nanoparticles, etc.) is needed, successfully developed more than 3 DDS products (including submission IND, clinical stage);

2)Related experience in foreign pharmaceutical companies and DDS products submitted to FDA is preferred;

(2) Ability Requirements:

1) Understand ICH, FDA and EMA guidelines, the national drug technology review requirements and drug registration laws and regulations;

2) Master formulation, processing and scale up technology. Have a strong ability to solve problems of NDDS products (especially production scale up and technology transfer), familiar with the quality requirements of the product;

3) Have the experience of preparation formulation and processing in accordance to the QbD concept requirements, familiar with requirements such as DOE, risk analysis and control, scale up, modification, technology transfer, validation and so on;

4) Strong project management and team management capabilities, able to provide guidance and training for R&D personnel. Very familiar with the development and direction of the world new formulations, with forward-looking vision;

  1. Language: Good communication and writing skills in Chinese and English.

 

 

Infusion Bag Materials

膜材研发技术总监

岗位职责:

1、领导包材研发团队开展多层共挤膜研究:负责多层共挤膜的配方和生产工艺研发。

2、领导管控膜材研究进度,使不同膜材满足不同药品的要求。

3、领导解决项目研发过程中的关键技术问题:如产品质量均一问题、相容性问题、弱焊问题、灭菌问题、密封性问题等。

 

岗位描述:

非常熟悉多层共挤膜的研究,具有国外膜材生产管理经验优先考虑,具备团队综合管理和执行管理能力。

1、学历及专业要求:本科及以上学历;高分子材料或高分子加工相关专业。

2、语言要求:有基本的中文沟通能力。

3、工作经验:10年以上多层共挤膜的研发和生产经验,有在日本膜材公司从业经验者优先考虑。

 

CMC

职位名称:合成工艺总监

工作地点:中国.成都

工作类型:全职

工作职责:

1、指导合成工艺团队设计原料药合成工艺路线,指导完成中试及放大生产研究;

2、指导制定原料药研究项目的研究计划,并按方案推进研究进度;

3、指导解决项目推进过程中的重大关键技术问题;

4、指导撰写、整理、审核注册申报资料和原始记录以及注册申请中相应的现场核查工作。

 

任职要求:

1、学历要求:硕士及以上学历;

2、专业要求:药物化学、化学合成等相关专业;

3、工作经验:

(1)10年以上化学原料药合成工艺研究从业经验,成功主持多项原料药新药开发;

(2)有在海外制药公司从业经验者优先;

4、能力要求:

(1)具有很强的解决问题能力,能熟练的设计出合理的合成路线和优化反应,熟悉化合物的分离、分析手段,并能进行专业的解析;

(2)熟悉国家药品技术审评要求及新药注册的相关法规;

(3)优秀的团队管理和执行能力;

(4)具有较强的沟通能力和责任心,能为研发人员提供指导和培训;

5、语言要求:良好的中、英文沟通及写作能力,能撰写、审核英语申报资料者优先。

 

Job Title: Director of chemical process R&D

Job Location: Chengdu, China

Job Type: Full-time

Job Description:

  1. Lead the process team to develop the synthetic route of API, and scale up the process up to manufacturing production scales;
  2. Make project R&D and production plan and provide the technic support to ensure the progress of the projects;
  3. Responsible for problem solving and correction, provide the technical support to development the process;
  4. Lead process team to complete drug filing based on ICH guideline and GMP requirements.

 

Job Requirements:

  1. Education: Ph.D. in Chemistry;
  2. Professional requirements: Pharmaceutical Chemistry, chemical synthesis and other related professional;
  3. Pharmaceutical working experience;

(1) 10+ years experience in drug development including developing new synthetic route for APIs, project management skills plus;

(2) Experience in overseas pharmaceutical company is preferred;

  1. Capability Requirements:

(1) Extensive scientific tracking record for problem solving in chemical synthesis and process development, familiar with basic separation technique and instrumentation analysis;

(2) Familiar with ICH guideline and Basic GMP manufacturing requirements and filing related regulations;

(3) Strong team management and leadership skills;

(4) Strong communication skills and sense of responsibility, capable provide guidance and training for R&D team member;

  1. Have written, verbal skills, and presentation skills in both Chinese and English. Able to review the English filing materials is preferred.

 

 

创新工艺总监

工作地点:中国·成都

工作类型:全职

工作职责:

  • 负责化合物从临床前候选化合物到IND阶段工艺研究的全程管理;
  • 解决工艺从路线设计、工艺优化及放大生产过程中出现的关键技术问题;
  • 把握工艺研究质量与尺度;
  • 负责创新工艺平台的建设与管理。

任职要求:

  • 学历要求:博士学历。
  • 专业要求:有机化学、药物化学专业。
  • 工作经验和能力要求:
  • 在国内外大型制药公司10年以上工艺研发经验;
  • 具备精通的工艺路线设计、工艺优化能力,具有丰富的工艺路线设计经验,具有创新药物工艺开发CMC全程管理经验者优先;
  • 熟悉工艺研究流程、工艺研究质量及药品研发的相关政策和法规;
  • 具有团队领导、管理能力。
  • 职业素养:积极敬业、主动进取、责任感强、正直向上。
  • 语言要求:良好的英文阅读、中文沟通及写作能力。

 

 

Director of Process Development

Job Location:Chengdu, China

Job Type:Full Time

Job Description

  1. Build and lead the process development group to support small molecule drug discovery and development programs.
  2. Manage the transfer of processes from laboratory to GMP manufacturing.
  3. Manufacture development in accordance with cGMP, agreed specifications and Quality standards.
  4. Write and review technical documentations such as reports, batch records, protocols and risk assessment.
  5. Write and review relevant reports for IND applications.

 

Job Requirement Competencies:

  1. PhD in organic chemistry or related disciplines.
  2. Over 10 years of synthetic process development experience within pharmaceutical industry with 5+ years in a project leading role.
  3. Experience in leading with multiple phases of product development is highly desirable.
  4. Excellent communication skills (oral, written, presentation) and strong project management skills.
  5. Experience in technical transfer to CMOs is highly desired.
  6. Good knowledge of GMPs, CMC authorization, regulatory audit and inspection experiences are preferred. Familiar with government regulations, CFDA/FDA CMC Guidance Documents will be an advantage.
  7. Strong project and team leading skills. Good Chinese and English language skills are essential.

 

职位名称:晶型研究总监

工作地点:中国.成都

工作类型:全职

工作职责:

1、负责创新药物的晶型和盐型筛选和工艺放大;

2、负责仿制药项目晶型攻关及新晶型研究;

3、负责晶型研究平台日常维护和管理工作;

 

任职要求:

1、学历要求:硕士及以上学历;

2、专业要求:药物化学、有机化学等相关专业;

3、工作经验:5年以上国内外晶型研究经验,有仿制药新晶型成功研发经验或创新药全面晶型研究及专利申请经历;

4、能力要求:

(1)具备丰富的晶型盐型研究经验,熟悉药物晶型研究流程;

(2)具有良好的沟通交流和执行能力;

5、语言要求:良好的中、英文沟通及写作能力。

 

Job Title: Director of polymorph in pharmaceuticals

Job Location: Chengdu, China

Job Type: Full-time

Job Description:

  1. In charge of Screening Polymorphs and process Scaling-up of innovative drugs;
  2. Responsible for tackling polymorph problems in Generic drugs. And manage routine daily jobs including the R&D work, documentation and planning;
  3. In charge of maintaining and managing the polymorph research platform.

 

Job Requirements:

  1. Master degree or above;
  2. Pharmaceutical Chemistry, organic chemistry and other related professional;
  3. Working experience: 5+ years researching experience of pharmaceutical polymorphs in domestic or abroad. Successfully and systematically experience of polymorph researching in Generic or new drugs. And patents application experience is preferred;
  4. Capability Requirement:

(1) Professional in polymorphs or crystal salt researching.  Familiar with the flow of polymorph research and development;

(2) Good communication and execution skills;

  1. Have written, verbal skills, and presentation skills in both Chinese and English.

 

 

职位名称:多肽纯化研究总监

工作地点:中国.成都

工作类型:全职

工作职责:

1、负责多肽药物的纯化、转盐小试和工艺放大的方案审核/制定、确认,以及执行过程中的全程管理;

2、负责多肽药物纯化、转盐工艺研究的技术指导和关键技术问题的解决;

3、负责多肽药物纯化、转盐平台日常维护和管理工作。

任职要求:

1、学历要求:硕士及以上学历;

2、专业要求:药物化学、有机化学、分析化学等相关专业;

3、工作经验:

(1)5年以上多肽纯化、转盐研究和放大经验;

(2)有多肽药物国内、国际注册申报成功经验;

4、能力要求:

(1)具备丰富的多肽药物纯化、转盐研究经验,熟悉多肽药物各种纯化、转盐工艺和手段的适用性,熟悉多肽从粗品到冻干品的全部研究流程;

(2)熟悉本领域国内外技术及法规,了解本领域国际前沿技术发展和应用;

(3)具有良好的沟通交流和执行能力;

5、语言要求:良好的中、英文沟通及写作能力。

 

Job Title: Director of polypeptide purification

Job Location: Chengdu Sichuan, China

Job Type: Full-time

Job Description:

  1. Responsible for the preparation and validation of peptide drug purification, salt transfer and scale-up, and the project management;
  2. Provide the technical support for the problem solving including development new process for solution and solid synthesis of peptide project;
  3. Responsible for the daily maintenance and management of the polypeptide purification and the salt transfer platform.

 

Job Requirements:

  1. Education: Master’s degree or above;
  2. Professional requirements: Pharmaceutical Chemistry, organic chemistry, analytical chemistry and other related professional;
  3. Pharmaceutical working experience;

(1) 5 + years experience in peptide purification, salt transfer and scale-up;

(2) Successful experience of domestic and international registration of polypeptide drugs;

  1. Capability Requirements:

(1) Have a good experience in the purification and transfer salt of peptide drugs, familiar with the various purification of peptide drugs, salt transfer process and the applicability of the method, familiar with the whole process of peptide from crude to freeze-dried products;

(2) Familiar with domestic and international technology and regulations, understand the international forefront of technology development and Application;

(3) Good communication and execution skills;

  1. Language skills: good communication and writing skills in both English and Chinese.

 

职位名称:油料API研究总监

工作地点:中国.成都/天津

工作类型:全职

工作职责:

  1. 组建药用油API研发技术平台;
  2. 组建和培养注射用油研发核心团队;
  3. 制定注射用油API开发战略,负责产品开发、工艺优化和申报注册等相关工作,并兼顾品种的引进及合作评估;
  4. 建立并实施药用油产品质量管理体系。

任职要求:

1、学历要求:硕士及以上学历;

2、专业要求:药学或相关专业;

3、工作经验和能力要求:五年以上药用油制备及纯化研发团队管理的工作经验;

4、职业素养:

(1)精通药用油研发技术理论知识,具备丰富的油类原料药及制剂研发经验;

(2)熟悉国家药品法律法规项目及要求;

5、语言要求:精通中、英文。

 

Job Title: Director of Pharmaceutical Oil

Job Location: Chengdu or Tianjin, China

Job Type: Full-time

Job Description:

  1. Lead scientific team to set up the plantform for the development of pharmaceutical oil;
  2. Provide the guideline and training program for team member and lead the core members successfully to complete project on the schedule;
  3. Responsible to schedule project timeline and detailed development strategy. Provide the guides and the technical support to reach the goal;
  4. Set up the Business Development plan and outsource plan;
  5. Set up the management system and project operation system to ensure process R&D and scale up production meets GMP requirements.

 

Job Requirements:

  1. Education: A Ph. D degree or experienced MS in Chemistry, food industry, material industry;
  2. Experience: At least five years of R&D experience, preferred in the pharmaceutical oil related field, familiar with the manufacturing production;
  3. Professional Skills: Extensive scientific tracking record and industry problem solving skills.
  4. Familiar with drug filling and GMP requirements;
  5. Language: English and Chinese.

  

Innovation Small Molecules

(1) 药物化学总监

工作地点:中国·成都

工作类型:全职

工作职责

  • 负责创新小分子的分子设计和化学合成的整体方案制定、研究质量和进度控制、专利查新、关键技术难题解决等药化研发的全过程管理;
  • 追踪国际创新分子发现及优化的新平台和新技术,及时掌握行业最新动态,提升团队研发实力和效率,为选题立项及国内外合作提供专业支持;
  • 协同药理团队挖掘临床前候选化合物的成药特点和品种优势;协同工艺团队开展小试和中试放大研究,降低生产成本,加快研发进度;
  • 负责创新分子的专利撰写、审核与跟进,确保公司知识产权的有效保护;
  • 负责相应团队的培训和建设、指挥与管理。

任职要求:

  • 学历要求:博士学历。
  • 专业要求:药物化学或有机化学专业。
  • 工作经验和能力要求:
  • 8年以上小分子药物研发经验和不少于5年的药化项目领导经验;
  • 有项目成功进入临床阶段者优先,有海外大型制药公司或著名药物研究机构工作经验者优先;
  • 具有专利解读与突破能力,理解药理毒理数据的生物学含义与成药属性的关系;
  • 熟悉国内外创新药开发模式、流程、技术要求及相关注册法规;
  • 具有良好的沟通交流和执行能力;
  • 具有良好的组织协调和团队管理能力。
  • 职业素养:积极敬业、主动进取、责任感强、正直向上。
  • 语言要求:良好的英文阅读、中文沟通及写作能力。

 

Director of Medicinal Chemistry

Job Location:Chengdu, China

Job Type:Full Time

Job Description

  1. Initiates, directs and executes chemistry efforts and strategies in research and/or development; also, plans and executes laboratory research pertaining to the chemistry group
  2. Designing small-molecule drug candidates based on in vitro and in vivo biological activity, ADME/PK, physicochemical and IP-relevant data.
  3. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  4. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Uses professional concepts in accordance with Kelun’s objectives to solve complex problems in creative and effective ways.
  5. Determine and follow program IP strategy and draft related patent documents for IP protection.
  6. Maintains broad knowledge of state-of-the-art principles and theories in drug discovery and makes major contributions to scientific literature and conferences.
  7. Determine methods and procedures on building of a strong and productive medicinal chemistry team.

Job Requirement Competencies:

  1. PhD in Chemistry plus 8-10 years’ industry experience or equivalent with 5 years in leading discovery chemistry programs.
  2. Expert knowledge of scientific principles and concepts required; must show demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
  3. Successful candidate should have a reputation as an emerging leader in the field with sustained performance and accomplishments.
  4. Excellent teamwork and collaboration skills; able to build effective working relationships throughout the organization internally and externally to achieve goals.
  5. Flexibility and willingness to solve problems that fall outside of immediate area of expertise.
  6. Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
  7. Work independently in an interdisciplinary, fast-paced and fast-changing environment.
  8. Committed to the values of integrity, accountability, transparency, and drive.

 

(2) 药效研究总监

工作地点:中国·成都

工作类型:全职

工作职责:

  • 负责创新小分子和生物技术药的药效研究整体方案制定、评价方法建立、研究质量和进度控制、关键技术难题解决等研发环节的全过程管理;
  • 追踪国际先进药效研究的发展趋势,特别是能反映人体内疾病真实情况的新平台新技术,降低研发风险,提升团队成药性评价水平和研发效率;
  • 与药代、毒理、临床等专业团队一起,分析研究在研品种的临床特点,提炼与临床标准治疗方案之间的优势,进一步提升成药性评价的科学性和系统性,并应用于临床前和临床研究中,提高临床研究的成功率;
  • 负责创新药物药理毒理申报资料的撰写和审核;
  • 负责相应团队的培训和建设、指挥与管理。

任职要求:

  • 学历要求:博士学历。
  • 专业要求:药理学、药学、医学、生物学等相关专业。
  • 工作经验和能力要求:
    • 在国内外大型制药公司6年以上创新药物药效研究经验,并在研发过程中担任项目负责人,成功推动项目进入临床或产品上市;或在CRO、科研院校长期从事药效研究;
    • 具备深厚的创新小分子或生物技术药的体内外药效研究能力,熟悉分子、细胞、尤其是动物模型等不同层次的药效评价技术与方法;
    • 熟悉新药研发流程,把握药效与药代、毒理等研究的相互联系,善于衔接相关研发环节、推动系统的成药性评价工作顺利开展者优先;
    • 熟悉药品研发注册的相关政策和法规,能指导申报资料撰写者优先;
    • 具有良好的组织协调能力和团队管理能力。
  • 职业素养:积极敬业、主动进取、责任感强、正直向上。
  • 语言要求:良好的英文阅读、中文沟通及写作能力。

 

Director of Pharmacology

Job Location:Chengdu, China

Job Type:Full Time

Job Description

  1. Responsible for pharmacological research of novel small molecule and biologic drugs, and management of R&D process including plan design, method establishment, quality and progress control, and problem solving.
  2. Follow trends of drug discovery from a pharmacological perspective, especially in novel platforms and technologies that improve depth and efficiency of project teams, reduce R&D risks, and help translation into the clinic.
  3. Closely work with teams of pharmacokinetics, toxicology, and clinical research, analyze clinical features of drug candidates in the pipeline, identify their potential in the standard of care, and improve rate of success in the clinic with better scientific and holistic evaluation of drug candidates.
  4. Responsible for writing and reviewing pharmacology and toxicology reports for IND applications;
  5. Responsible for training, managing, and leading project teams.

Job requirements:

  1. A doctoral degree in pharmacology, pharmacy, medicine, biology or related disciplines.
  2. Worked in pharmacology or related departments of domestic and international large pharmaceutical companies for more than 6 years; worked as a project lead and was able to successfully advance projects into the clinic, or worked in CRO companies or research institutions for extended periods.
  3. Able to carry out in vitro and in vivo pharmacological studies of small molecules or biologics, and evaluate techniques and methods at molecular and cellular levels, and in animal models.
  4. Familiar with R&D processes, understand relationships among different areas of research especially pharmacology, pharmacokinetics, and toxicology, and able to connect works at each stages of R&D. Ability to approach R&D systematically is preferred
  5. Familiar with relevant policies and regulations of new drug registration. Ability to guide the preparation of IND applications is preferred;
  6. Good organizational, managerial, and team work skills.
  7. Work proactively, with dedication, strong sense of responsibility, and integrity;
  8. Good communication skill, fluent in Chinese, proficient in English reading.

 

(3) 药代研究总监

工作地点:中国·成都

工作类型:全职

工作职责:

  • 负责创新小分子和生物技术药的药代动力学研究整体方案制定、评价流程建立、研究质量和进度控制、关键技术难题解决等研发环节的全过程管理;
  • 协同药效、毒理等专业团队开展系统的成药性评价工作,对在研品种进行准确的药代属性评价;
  • 根据临床前药代数据,建模预测人体药代参数,协助临床团队制定早期临床研究方案;
  • 负责药代试验的方案、正式报告审核、修订,指导创新药物药理毒理申报资料的撰写和审核。
  • 负责相应团队的培训、建设与管理,

任职要求:

  • 学历要求:博士学历。
  • 专业要求:药代动力学、药物分析、分析化学等相关专业。
  • 工作经验和能力要求:
  • 在国内外大型制药公司6年以上创新药物药代研究经验,并在研发过程中担任负责人,成功推动项目进入临床或产品上市;或在CRO、科研院校长期从事药代研究;
  • 具备资深的创新小分子或生物技术药的药代研究能力,具有丰富的DMPK知识和仪器分析经验;
  • 熟悉新药研发流程,把握药代与药效、毒理等研究的相互联系,善于衔接相关研发环节、推动系统的成药性评价工作顺利开展者优先;
  • 熟悉创新药研发流程,熟悉药品研发的相关政策和法规者优先;
  • 具有团队管理能力。
  • 职业素养:积极敬业、主动进取、责任感强、正直向上。
  • 语言要求:良好的英文阅读、中文沟通及写作能力。

 

Director of Pharmacokinetics

Job Location:Chengdu, China

Job Type:Full Time

Job Description

  1. Responsible for pharmacokinetic research of novel small molecule and biologic drugs, and management of R&D process including plan design, method establishment, quality and progress control, and problem solving.
  2. Closely work with teams of medicinal chemistry, pharmacology, and toxicology in evaluation of leads and drug candidates.
  3. Assist early clinical research in modeling and estimation of clinical PK parameters applying preclinical PK data
  4. Responsible for PK experimental design, writing and reviewing relevant reports for IND applications;
  5. Responsible for training, managing, and leading project teams.

Job requirements:

  1. A doctoral degree in pharmacokinetics, drug analysis, analytical chemistry, or related disciplines.
  2. Worked on pharmacokinetics in domestic and international large pharmaceutical companies for more than 6 years; worked as a PK representative and was able to successfully advance projects into the clinic, or worked in CRO companies or research institutions for extended periods.
  3. Able to carry out PK studies of small molecules or biologics, with extensive experience in DMPK research and instrumentation
  4. Familiar with R&D processes, understand relationships among different areas of research especially pharmacology, pharmacokinetics, and toxicology; and able to connect works at each stages of R&D. Ability to approach R&D systematically is preferred
  5. Familiar with relevant policies and regulations of new drug registration. Ability to guide the preparation of IND applications is preferred;
  6. Good organizational, managerial, and team work skills.
  7. Work proactively, with dedication, strong sense of responsibility, and integrity;
  8. Good communication skill, fluent in Chinese, proficient in English reading.

 

 

(4) 毒理研究总监

工作地点:中国.成都

工作类型:全职

工作职责:

  • 负责创新小分子和生物技术药的毒理研究整体方案制定、研究质量和进度控制、关键技术难题解决等研发环节的全过程管理;
  • 协同药效、药代等专业团队开展系统的成药性评价工作,对在研品种进行准确的安全性评价和分析研究潜在的临床毒性;
  • 根据临床前研究结果,协同药效和临床团队进行首次人体试验(FTIH)方案的设计;
  • 负责GLP毒理试验方案和正式报告的审阅、修订工作,指导药理毒理申报资料撰写;
  • 负责相应团队的培训和建设、指挥与管理。

 

任职要求:

  • 学历要求:博士学位。
  • 专业要求:药理学、毒理学等相关专业。
  • 工作经验和能力要求:
  • 在国内外大型制药公司6年以上创新药物毒理研究经验,并在研发过程中担任负责人,成功推动项目进入临床或产品上市;或在CRO、科研院校长期从事毒理研究;
  • 熟悉新药开发模式和流程,具有深厚的GLP毒理知识及丰富的毒理试验经验,能够独立组织和协调临床前毒理相关研究工作的开展和落实;
  • 精通国内外GLP的法规要求和临床前安全性评价相关指导原则;
  • 熟悉新药研发流程,把握毒理与药效、药代等研究的相互联系,善于衔接相关研发环节、推动系统的成药性评价工作顺利开展者优先;
  • 具有团队管理能力。
  • 职业素养:积极敬业、主动进取、责任感强、正直向上。
  • 语言要求:良好的英文阅读、中文沟通及写作能力。

 

Director of Toxicology

Job Location:Chengdu, China

Job Type:Full Time

Job Description

  1. Responsible for toxicological research of novel small molecule and biologic drugs, and management of entire research and development process including plan design, method establishment, quality and progress control, and problem solving.
  2. Closely work with teams of chemistry, pharmacology, and pharmacokinetics in holistic evaluation of leads and drug candidates, determine preclinical safety parameters and analyze potential safety risk in the clinic.
  3. Assist pre-clinical pharmacology and clinical research in designing First-In-Human trials
  4. Responsible for designing GLP safety studies, writing and reviewing pharmacology, pharmacokinetics and toxicology reports for IND applications;
  5. Responsible for training, managing, and leading project teams.

Job requirements:

  1. A doctoral degree in pharmacology, toxicology, or related disciplines.
  2. Worked on toxicology in domestic and international large pharmaceutical companies for more than 6 years; worked as a safety and toxicology representative and was able to successfully advance projects into the clinic, or worked in CRO companies or research institutions for extended periods.
  3. Familiar with R&D processes, had extensive knowledge and experience in GLP toxicological studies, able to independently organize and coordinate pre-clinical safety and toxicology research.
  4. Familiar with domestic and international GLP policies and regulations relating to pre-clinical safety studies. Ability to guide the preparation of IND applications is preferred;
  5. Understand relationships among toxicology, pharmacology, and pharmacokinetics; and able to connect works at each stages of R&D. Ability to approach R&D systematically is preferred
  6. Good organizational, managerial, and team work skills.
  7. Work proactively, with dedication, strong sense of responsibility, and integrity;
  8. Good communication skill, fluent in Chinese, proficient in English reading.

 

(5) 计算化学总监

工作地点:中国.成都

工作类型:全职

工作职责

  • 负责创新药物的计算机辅助药物设计平台建设, 指挥与管理,为新分子设计提供技术指导和支持;
  • 利用现代计算化学技术原理,为科伦创新研发项目进行分子设计,快速实现临床前候选化合物的发现和提名;
  • 和其他药物研发团队一起制定和推进药物研发的策略;
  • 领导实现“先设计再合成”(Design before Synthesis)的高效药物研发模式;
  • 积极参与科伦药物研发方面的人才招聘;
  • 积极跟踪计算机辅助药物设计最新动态,及时引进新技术,新方法。

 

任职要求:

  • 学历要求:博士学历。
  • 专业要求:计算化学、药物化学、有机化学等相关专业。
  • 工作经验和能力要求:
    • 5年以上新药研发领域的计算机辅助药物化学经验;
    • 能熟练进行蛋白和小分子模型构建,能利用蛋白和小分子模型以及生物晶体结构等独立进行计算机辅助药物设计,开展分子对接和虚拟筛选研究;
    • 具有良好的沟通交流和执行能力,熟悉药物化学基本原理及分子成药性基础;
    • 具有良好的组织协调能力和团队管理能力。
  • 职业素养:积极敬业、主动进取、责任感强、正直向上。
  • 语言要求:良好的英文阅读、中文沟通及写作能力。

 

Director of Computational Medicinal Chemistry

Job Location:Chengdu, China

Job Type:Full Time

Job Description

  1. Build and manage a computational medicinal chemistry platform.
  2. Design and optimization of novel drug candidates using advanced computational techniques, taking on roles of responsibility within portfolio programs, and scientific talent development.
  3. Collaboration with discovery teams to invent novel medicines including defining project strategy and driving execution.
  4. Championing a “design first” strategy within project teams to achieve better molecules faster
  5. Active participation in recruitment, training and development of staff within the computational medicinal chemistry group.
  6. Continuing research in new areas of molecular modeling relevant to drug discovery and development.
  7. Maintaining an external scientific presence including authoring significant scientific publications and presentations.

 

Job Requirement Competencies:

  1. D. in either Chemistry, Biochemistry, Biophysics, or equivalent, preferably with a computational chemistry emphasis.
  2. Minimum of 5 year experience of molecule modelling and/or chem-informatics in the Pharmaceutical Industry.
  3. Strong communication skills, along with the ability to work well in multidisciplinary teams.
  4. Evidence of creative application of computational approaches to problems of biological or chemical interests.
  5. Good Chinese and English language skills.

(6) 创新药物制剂总监

工作地点:中国·成都

工作类型:全职

工作职责:

  1. 主持创新药物制剂开发工作,保证研究的系统性和规范性;
  2. 负责剂型设计,制定制剂研发方案及计划,把控制剂研究进度,解决项目中的关键技术问题;
  3. 与相关团队协作,从制剂角度对选题立项、分子设计及临床前研究等提供必要的技术支持及建议,推动药物的成药性研究和临床研究顺利进行,降低创新药物研发风险;
  4. 指导中英文申报资料的撰写和审核;
  5. 负责相应团队的培训和建设、指挥与管理。

任职要求:

  1. 学历要求:硕士或以上学历。
  2. 专业要求:药物制剂及相关专业。
  3. 工作经验和能力要求:

(1) 在国内外知名制药企业从事制剂研发工作5年以上;

(2) 主持或参与3个以上1.1类新药制剂开发工作,有各种类型制剂研发经验者,或有成功的1.1类新药获批经验者优先;

(3) 具有按照QbD理念进行制剂处方工艺开发经验者优先;

(4) 熟悉药品注册的相关法规及技术审评要求;

(5) 具有扎实的制剂技术及工艺知识,具有极强的解决制剂研发关键技术问题

的能力;

(6) 熟悉药物制剂处方筛选、工艺优化及工业化生产的流程和技术,熟悉新药开发不同阶段的制剂产品质量要求。

  1. 职业素养:积极敬业、主动进取、责任感强、正直向上。
  2. 语言要求:
    • 良好的英文阅读、中文沟通及写作能力;
    • 能熟练使用英语与他人交流。

 

 

Director of Formulation Development

Job Location:Chengdu, China

Job Type:Full Time

Job Description

  1. Lead Drug Product Formulation Development. Responsible for strategic planning, coordinating, and execution of the drug product formulation development / characterization activities.
  2. Determine and design dosage forms of drug candidate based on projected future clinical use, physicochemical properties, IP and other relevant date.
  3. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  4. Interact closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements.
  5. Writing and reviewing relevant reports for IND applications.
  6. Responsible for training, managing, and leading project teams.

 

 

Job Requirement Competencies:

  1. PhD in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and a minimum of 8 year experience in a development environment.
  2. 3+ year experience in leading small molecule formulation development with demonstrated successful IND application filing.
  3. Experience in leading with multiple phases of product development is highly desirable.
  4. Excellent communication skills (oral, written, presentation) and strong project management and demonstrated problem solving skills.
  5. Good knowledge of GMPs, CMC authorization, regulatory audit and inspection experiences are preferred. Familiar with government regulations, CFDA/FDA CMC Guidance Documents will be an advantage.
  6. Ability to work in a fast-paced, dynamic, environment.
  7. Strong project and team leading skills.
  8. Good Chinese and English language skills are essential.

 

  • 创新工艺总监

工作地点:中国·成都

工作类型:全职

工作职责:

  1. 负责化合物从临床前候选化合物到IND阶段工艺研究的全程管理;
  2. 解决工艺从路线设计、工艺优化及放大生产过程中出现的关键技术问题;
  3. 把握工艺研究质量与尺度;
  4. 负责创新工艺平台的建设与管理。

任职要求:

  1. 学历要求:博士学历。
  2. 专业要求:有机化学、药物化学专业。
  3. 工作经验和能力要求:
  • 在国内外大型制药公司10年以上工艺研发经验;
  • 具备精通的工艺路线设计、工艺优化能力,具有丰富的工艺路线设计经验,具有创新药物工艺开发CMC全程管理经验者优先;
  • 熟悉工艺研究流程、工艺研究质量及药品研发的相关政策和法规;
  • 具有团队领导、管理能力。
  1. 职业素养:积极敬业、主动进取、责任感强、正直向上。
  2. 语言要求:良好的英文阅读、中文沟通及写作能力。

 

Director of Process Development

Job Location:Chengdu, China

Job Type:Full Time

Job Description

  1. Build and lead the process development group to support small molecule drug discovery and development programs.
  2. Manage the transfer of processes from laboratory to GMP manufacturing.
  3. Manufacture development in accordance with cGMP, agreed specifications and Quality standards.
  4. Write and review technical documentations such as reports, batch records, protocols and risk assessment.
  5. Write and review relevant reports for IND applications.

Job Requirement Competencies:

  1. PhD in organic chemistry or related disciplines.
  2. Over 10 years of synthetic process development experience within pharmaceutical industry with 5+ years in a project leading role.
  3. Experience in leading with multiple phases of product development is highly desirable.
  4. Excellent communication skills (oral, written, presentation) and strong project management skills.
  5. Experience in technical transfer to CMOs is highly desired.
  6. Good knowledge of GMPs, CMC authorization, regulatory audit and inspection experiences are preferred. Familiar with government regulations, CFDA/FDA CMC Guidance Documents will be an advantage.
  7. Strong project and team leading skills. Good Chinese and English language skills are essential.

 

  • ADC药物研究总监

工作地点:成都或苏州

2、工作职责

  • 领导单克隆抗体偶联药物(ADC)的研发,负责ADC毒素、linker的设计、合成;
  • 领导优化ADC抗体偶联药物;
  • 指导、解决项目实施过程中的关键技术难题;
  • 负责ADC质量标准和SOP的制定及执行;
  • 负责团队培训、考核及管理工作;

3、任职要求:

  • 学历要求:博士;
  • 专业要求:药物化学、生物化学或有机合成等相关专业;
  • 工作经验:国内外药企8年以上相关经验;
  • 能力要求:在ADC药物研发方面以及癌症生物学方面具有较丰富的经验;熟悉ADC的最新研究进展;从事过研发团队管理工作者优先考虑;有国外药企工作经验者优先考虑;
  • 语言要求:具备良好的英文读写和交流能力

 

Other Positions

❶职位名称:分院院长(副院长)

工作地点:中国•苏州/天津 美国.新泽西

工作类型:全职

工作职责:

  1. 根据公司发展战略制定分院药物研究整体计划及实施方案;
  2. 全面负责分院的团队建设和组织管理,协调分院的各项业务;
  3. 全面负责研发项目的质量和进度管理,定期和不定期向总院述职,并提交相关报告;
  4. 指导分院各部门业务的开展,对实施过程中的瓶颈性问题提供必要的技术指导;
  5. 根据发展战略、年度计划及目标要求,制定年度科研费用预算,并按预算管理科研费用;
  6. 接受总院的其他工作安排。

 

任职要求:

  1. 学历要求:硕士及以上学历。
  2. 专业要求:药学、医学、制药工程、有机化学、药物化学、药理学等相关专业。
  3. 工作经验和能力要求:

(1)10年以上药物研发管理经验,具有100人以上研发团队管理经验者优先;

(2)熟悉药品研发的法律法规,具有丰富的领导开发新药及仿制药并获得生产批件的经验;

(3)有丰富的药学、医学知识,熟悉专利法及药品市场动态,具有药物研发大局观;

(4)具有良好的创新思维、战略规划、组织协调和团队管理能力;

(5)具有良好的沟通交流能力及执行力。

  1. 职业素养:积极敬业、主动进取、责任感强、正直向上。
  2. 语言要求:良好的英文阅读、中文沟通及写作能力。

 

职位名称:分析总监

工作地点:中国·成都

工作类型:全职

工作职责:

1、负责新型给药系统质量研究:研究方案审核与修订、研究结果评价与审核、申报资料及质量标准审核;

2、负责研究项目的管理,包括研究项目进度管控、资源的调配、保证质量研究申报资料符合申报注册法规要求等;

3、引进、完善新型给药系统质量研究分析技术,解决质量研究中分析技术问题;

4、负责相应团队的培训和建设、指挥与管理。

 

任职要求:

1、学历要求:硕士及以上学历;

2、专业要求:药物分析及相关专业;

、工作经验:

(1)具有10年以上制药企业药物质量研究经验,包括分析方法学研究、稳定性研究和质量标准建立;

(2)具有新型给药系统(重点在脂质体、微球、缓控释制剂)相关的质量分析经验;

(3)具有多个项目申报经验;

(4)有海外制药公司从业经验者优先;

4、能力要求:

(1)熟悉原料药及制剂分析方法和质量研究; 具有扎实分析化学、药物化学基础;

(2)具有对文献或研究结果进行综合分析、判断的能力;

(3)熟悉了解药物研发流程和相关的政策法规;

(4)具有团队管理能力;

5、职业素养:积极敬业、主动进取、责任感强、正直向上;

6、语言要求:良好的沟通及写作能力。

 

职位名称:质量分析技术总监

工作地点:中国·成都/苏州/天津

工作类型:全职

工作职责:

1、负责仿制药质量研究:研究方案审核与修订、研究结果评价与审核、申报资料及质量标准审核;

2、负责研究项目的管理:研究项目进度管控、资源的调配、保证质量研究申报资料符合申报注册法规要求;

3、质量研究相关SOP撰写、审核;

4、引进、完善质量分析技术,解决质量研究中分析技术问题;

5、负责相应团队的培训和建设、指挥与管理。

 

任职要求:

1、学历要求:硕士及以上学历;

2、专业要求:药物分析及相关专业;

3、工作经验:

(1)具有10年以上制药企业药物质量研究经验,包括分析方法学研究、稳定性研究和质量标准建立;

(2)具有多个项目申报经验;

(3)有一定的特殊制剂相关的质量分析经验;

(4)有大型制药公司从业经验者优先;

4、能力要求:

(1)熟悉原料药及制剂分析方法和质量研究; 具有扎实分析化学、药物化学基础;

(2)具有对文献或研究结果进行综合分析、判断的能力;

(3)熟悉了解药物研发流程和相关的政策法规;

(4)具有团队管理能力;

5、职业素养:积极敬业、主动进取、责任感强、正直向上;

6、语言要求:良好的沟通及写作能力。

 

Job Title: Director of Analytical R&D

Job Location: Chengdu/Tianjin/Suzhou, China

Job Type: Full-time

Job Description:

  1. Lead and manage analytical teams that conduct analytical research in ANDA and/or in pre-FIH through commercial registration with high scientific rigor and implementation of analytical process control strategies to advance small molecule drug discovery candidates;
  2. Develops and implements quality standards and specifications for drug substance and drug products under development and reviews and ensures the delivery of high quality-related sections in CMC sections of IND/ANDA/NDA filings. Addresses quality-related inquiries from regulatory agencies to support clinical trial and commercial marketing applications;
  3. Work collaboratively with other functional areas outside Analytical to advance projects through the pipeline;
  4. Support new product development with advanced method development and validations, technical transfer packages, and generation of technical data in support of clinical API and drug product regulatory requirements;
  5. Ensure the development of strategies that drive scientific excellence and innovations that improve the future capabilities and productivity of the greater organization;
  6. Responsible for leadership and technical development within the function generating future leadership for the function. This includes establishing a sustainable high functioning team, managing performance of the team and in conjunction with team members, developing career paths for growth;
  7. Form strong cross-functional alliances across R&D and Commercial Manufacturing Operations to ensure robust and effective process development control strategies with efficient analytical technical transfer;
  8. Assures compliance with Kelun safety, quality and regulatory policies and government regulations.

 

Job Requirements:

  1. Master, or PhD in Analytical Chemistry or relevant scientific discipline with a minimum of 10 years related industry experience;
  2. Strong technical background in analytical chemistry;
  3. Demonstrated leadership of technical teams and effective cross-functional communication;
  4. Demonstrated capability to solve critical scientific and business problems;
  5. Demonstrated ability to implement and to grow capabilities of an analytical organization and develop people into future leaders;
  6. Extensive experience in drug substance and drug product process development, scale-up from pilot plant to a commercial facility, and analytical tech transfer to R&D and QC laboratories;
  7. Understanding of cGMP and regulatory requirements;
  8. Excellent written and communication skills to effectively represent the analytical issues with internal project and CMC teams, external contract organizations and senior management.

 

 

创新分析总监

工作地点:中国·成都

工作类型:全职

工作职责:

  • 负责创新药物从先导化合物发现到IND申报整个过程的分析,分离纯化,结构鉴定,质量分析的整体管理和技术指导;
  • 负责IND申报资料中相关资料的撰写和审核;
  • 负责创新分析团队的建设与管理。

任职要求:

  • 学历要求:硕士及以上学历。
  • 专业要求:药物分析、分析化学等相关专业。
  • 工作经验和能力要求:
  • 具有5年以上创新药物分析工作经验;
  • 具有创新药物的质量分析研究能力,熟悉创新药研发流程;
  • 具有深厚的药物分析理论知识及丰富的分析仪器操作经验;
  • 熟悉创新药品研发注册的相关政策和法规,具有指导申报资料撰写和审核的能力。
  • 职业素养:积极敬业、主动进取、责任感强、正直向上。
  • 语言要求:良好的英文阅读、中文沟通及写作能力。

 

 

Director of Analytical Chemistry

Job Location:Chengdu, China

Job Type:Full Time

Job Description

  1. Build an analytical platform and provide analytical support for the drug discovery and product development programs for IND applications.
  2. Lead the development of methods, method evaluation and verification for related to the testing and characterization of therapeutics using analytical instrumentation and methodologies.
  3. Responsible for data interpretation, report preparation and regulatory compliance of development programs.
  4. Lead the creation/revision of SOPs, COAs, protocols.
  5. Provide analytical support for CMC activities; writing and reviewing relevant reports for IND applications.

 Job Requirement Competencies:

  1. D. in Chemistry or related discipline, with +8 years’ experience in the pharmaceutical industry, or an equivalent combination of education and experience. Experience with multiple phases of product development from the analytical perspective is highly desirable.
  2. Broad experience with computerized analytical instruments, databases, and spreadsheets; knowledge of cGMP; and good technical writing, problem-solving, and communication skills. Time management skills are critical to this position.
  3. Excellent communication skills (oral, written, presentation) and strong project management skills.
  4. Experience in method transfer to CMOs is highly desired.
  5. Good knowledge of GMPs/GLPs. CMC authorization, regulatory audit and inspection experiences are preferred. Familiar with government regulations, ICH, CFDA/FDA CMC Guidance Documents will be an advantage.

 

If interested in any of the positions, please contact Guibao Gu at guibao.gu@kluspharma.com or call 858-245-9018.

For more information about the company, please visit www.kelun.com.