STA – China Based Positions

1、Senior Scientist of Process Research & Development (PRD)
Responsibilities:
• Capable of literature search and synthetic route design
• Risk assessment and troubleshooting during project planning and execution
• Lead a group of process R&D scientists and manage at least 2 projects throughout process R&D and manufacturing
• Participate quotation for request for proposal
• Keep tracking on the progress of all the projects including project planning, problem solving and on-time delivery to ensure the success of all projects
• Cooperate with multiple function teams in integrated drug discovery service with focus on API development & manufacturing
• Provide innovation during process R&D
• Prepare documents of process R&D reports, mater batch record and final campaign report
• Familiar with plant operation and GMP guidelines and instruct process chemists to coordinate the production work involving QC, QA, procurement, logistics, operation teams, etc.
• Responsible for equipment reservation and raw materials ordering & tracking for lab R&D and plant production
• Serve as key contact person for communication with clients including but not limited to teleconference meetings. email communications and written updates
• Train and coach subordinate scientists on organic and process chemistry
• Compliance of company SOP including subordinate
Qualifications:
• Ph.D. in organic or medicinal chemistry with 2 years’ process chemistry experience
• Thorough knowledge of synthetic organic chemistry
• Working knowledge of analytical instrumentation and methods, chemical literature, Office and ChemDraw software and literature searching
• Good verbal and written communication in English
• Demonstrated work ethic, sound judgment, excellent oral and written communication skills and teamwork spirit
Location:
Pudong District, Shanghai City / Changzhou City, Jiangsu Province

2、Principal Scientist of Process Research & Development (PRD)
Responsibilities:
• Excellent knowledge in organic chemistry and organic synthesis, extensive experience in literature search and route selection, and familiar with spectra interpretation and compound identification.
• Able to independently design new route routes and explore the alternative synthesis.
• Capable of handling multiple complex projects at the same time, preparing the project plans, executing the plans and solving potential problems.
• Familiar with plant equipments and operations, providing production support and conducting trouble-shooting in the plant to ensure the success of the manufacturing.
• Complete weekly dates, final reports and campaign reports in a timely manner.
• Teleconference with the clients. Able to discuss the technical issues with the clients and answer the clients’ questions.
• Lead a small team with a few chemists, coach and train junior chemists.
• Implement and comply with company and department policies such as EHS and IP policy.
Qualifications:
• Master degree or above in organic chemistry, medicinal chemistry, chemical engineering, or related fields.
• Extensive knowledge and hands-on experience in organic chemistry, process R&D and GMP regulations.
• Excellent in oral presentation and written communication in English. Skilled on Microsoft Word, Excel and PPT, chemdraw software etc.
• As a master, 7 years or above experience in organic synthesis or process R&D and 4 years or above research projects management. As a doctor, 3 years or above experience in organic synthesis or process R&D and 2 years or above research projects management.
• Excellent skills in problem solving, communications, project management and coordination, and team building.
Location:
Pudong District, Shanghai City / Changzhou City, Jiangsu Province

3、 Director of Process Research Development (PRD)
Responsibilities:
Projects
• Be able to handle one or more major cooperation.
• Be aware of all the requirements on all the projects in the department such as priority, timeline and other special requirements from clients.
• Finalize the research plan and the execution program; Ensure the team fully understand the whole plan and guideline to solve the issues during execution; avoid the impact on the progress and the timeline of the whole project when issues occur.
• Coordinate all the resource and make adjustment according to the progress and timeline on time.
• Immediately communicate with upper management and clients when issues to impact the progress and plan of the projects occur; and provide backup plan to ensure success of the project.
• Review COA of products.
Management
• Be able to lead multiple groups (30 chemists or above) simultaneously
• Be able to manage multiple projects (10 projects or above) simultaneously
• Be able to manage client’s projects dependently (3 clients’ project or above)
• Organize all kinds of the trainings on the whole team to continuously improve the ability of the team
• Promote talented team members and evaluate on all the group leaders or team remembers
• Optimize the workflow and involve the daily management of the department
• Recruit new staff and provide trainings
• Ensure team members to strictly comply with all the policies of company and department. Daily Check lab safety , notebook and IP
• Ensure the personal safety of team members and the safety of labs. Investigate and prevent any violations and accidents.
Communication
• Communicate with clients efficiently by TC or email (carefully organize the materials and the detailed information)
• Ensure clients to be satisfied with our communications
• Ensure all the reports (including weekly update, final report , PPT file and campaign report) to be ready on time
• Response to clients immediately by TC or email for some special requirements.
• Assist to build good relationship with clients and to arrange visit for clients.
Qualifications:
• Master or PhD in organic chemistry or equivalent degree.
• Be proficient in organic chemistry, process R&D and GMP regulations.
• Excellent in presentation and communication in English.
• 5 years or above experience (PhD) in organic synthesis or process R&D, 3 years or above projects management experience.
• 9 years or above experience (Master) in organic synthesis or process R&D, 5 years or above projects management experience.
• Demonstrate ability in problem solving, communications, project management and coordination, and team cooperation.
Location:
Pudong District, Shanghai City / Changzhou City, Jiangsu Province

4、Senior Director or Executive Director of Process Research & Development (PRD)
Responsibilities:
• Manage all responsible projects, including setting project priority and delivery timelines. Meet customer requirements by understanding the customer needs.
• Make decision on the project plan and is responsible for executing the plan. Ensure that your group members have full understanding of the project plan. Provide technical guidance to the staff and troubleshoot project issues in a timely manner to ensure smooth progress of the project.
• Properly allocate resources to all projects and make adjustments whenever is needed, ensuring that every project meets delivery timeline.
• When the delivery timeline of a project is impacted, immediately report to upper management and communicate with the customer. Propose solutions and modify the project plan if needed to ensure the success of the project. Communicate with the customer, including writing project proposal, organizing tele-conference with the customer, reviewing and updating reports on ongoing projects, setting project priority and preparing project final report.
• Communicate with the customer in a timely manner and ensure customer satisfaction. The average annual score of customer survey is not lower than B, and try to be A.
• Recruit new staff and ensure that they receive proper and adequate trainings. Coach staffs so that they continuously improve their work skills. Review and rank group member performance.
• Promote ≥ 5 talented group members every year.
• Conduct daily management of your group, establish and improve the workflow of your group. Bring the operating costs of your group under budget and improve the work efficiency of your group.
• Provide coaching to your group members and prepare training documents.
• Ensure that your group members receive proper trainings, be developed and coached to comply with company and department policies, especially IP protection policy.
• Ensure the personal safety of your team members and the safety of your labs. Establish and implement lab SOP, and investigate any lab accident and propose solutions to prevent the occurrence of such event.
Qualifications:
• PhD or Master in organic chemistry or equivalent degree. Be proficient in organic chemistry, process R&D and GMP regulations.
• More than 12 years experience in organic synthesis or process R&D; more than 6 years work experience after PhD graduation; more than 4 years project management experience.
• Excellent in presentation and communication in English
• Demonstrate ability in problem solving, communications, project management and coordination, and team building.
• Recognized in the Industry and the scientific community for his/her in-depth expertise in regulated process research and development and proven scientific accomplishments.
• Distinguished for his/her ability to envision new business opportunities, create strong relationships with clients, as well as to make things happen at operational level.
• Demonstrate outstanding and balanced participative/directive and process leadership.
• A talent for fostering resources optimization, continuous improvement and operational efficiency.
• Exceptional aptitudes for analyzing problems and finding innovative solutions.
• Proven ability to motivate, mentor and work efficiently, as well as with persons from other cultures, as in cross-functional and self-directed work teams
Location:
Pudong District, Shanghai City / Changzhou City, Jiangsu Province

5、Director of Process Engineering (PE)
Responsibilities:
• Responsible for team management and coordination between various parties including plant EHS for project execution.
• Read journal and other technical papers, find new opportunities in the area of work, and give direction to the team..
• Continuously enhance performance of the team.
• Identify and recommend process safety tests for a process step to ensure process safety of the step in lab, kilolab, and the plant..
• Acts as a lead author on technical reports, is a resource for technical expertise on process safety assessment.
• Attend the process safety assessment meeting and give well-organized presentations.
• Act as a mentor to the junior scientist, plan experiments for other scientists.
• Investigates the use of new technology/equipment for process safety related work.
• Responsible for overall lab safety.
• Responsible for repair of the equipment.
• Satisfactorily completes all trainings including cGMP, GLP and/or safety training as applicable to job requirements.
• Strictly implement the departmental SOP, and have some reasonable suggestion.
• Maintain the departmental 5S policy.
• Comply with the company rules, like EHS/ IP etc.
• Perform experiments in a safe manner to self and others. Contribute in housekeeping of the laboratory.
• Perform any other tasks assigned.
• Ensure department compliances such as IP and safety
• Fully and independently responsible for Process Safety Evaluation team
Qualifications:
• Bachelor or above in Applied Chemistry/Applied Chemistry/Chemical Engineering or related majors
• At least 8 years in PRD / plant environment, focus on Process Safety, flow chemistry or crystallization.
• Management, optimized utilization of resources, planning, and scheduling. Leading cross functional teams in the area of Safety in Lab and plant
• Good ability of coordination and communication, and good English.
• Good ability of problem investigation and logical thinking.
• Following customer need,Guarantee smooth production.
Location:
Pudong District, Shanghai City / Changzhou City, Jiangsu Province

6、Director of Commercial Project Management
Responsibilities:
• Leading a Commerical Manufacturing team to enable Process Validations and Commercialization of late phase projects via overseeing the relevant activities, such as, preparations of the quotations, equipment selection, production scheduling, material management, deviation handing, product shipment, etc.
• Collaborating with Process R&D team to oversee the technological transfers from the lab to the manufacturing site
• Working with a matrix environment, along with different site functions, e.g. Production, QC, QA, HSE, Engineering, to ensure the deliverables of Process Validations and Commercial campaigns
• Launching or supporting new site initiatives and procedures to improve productivity and enhance the pivotal role of Commerical Manufacturing team during tech. transfers
• Communicating effectively with clients as the technical representatives during Process Validation and Commerical campaigns
• Recruiting new staff, coaching/training team members and retaining the high-caliber associates for the sustainable growth and development of the team
• Ensuring the team to comply with company policies, e.g. IP protection, safety, etc

Qualifications:
• Master of Science degree or above in organic chemistry or chemical engineering.
• 10+ Years of experience in pharmaceutical plant under GMP environment is preferred.
• Proficient English skills in listening, speaking reading, and writing.
• Excellent problem solving skills.
• Self-motivator with ability to work independently.
• Strong team player with good communication and coordination skills.
• High energy level with strong customer service mind.
Location:
Jinshan District, Shanghai City / Changzhou City, Jiangsu Province

7、Senior Scientist of Analytical R&D (Process Analytical and Formulation Analytical)
Responsibilities:
• Carry out analytical research and development for pharmaceutical process development and manufacture;
• Take a leadership role in a research group to ensure projects moving forward on time;
• Operate and maintain analytical instruments and equipments;
• Design, conduct and direct studies, analyze data to draw sound conclusions;
• Solve technical problems in method development, validation and sample testing;
• Communicate with clients on project progress, research results, challenges and solutions in English, and answer queries in a timely basis;
• Compile guidelines, procedures and work plans, generate/revise reports and present/review results;
• Be familiar with ICH Guidelines, USP, EP and CP.
Qualifications:
• Ph.D. or MS degree in analytical chemistry or related majors
• Proven research skills as shown in scientific publications and hands on experience in pharmaceutical development projects;
• Good written and oral English;
• Good communicational and interpersonal skills;
• Good computer skills for MS Office, Chemdraw, data analysis and presentation;
• Capabilities of handling multiple tasks simultaneously, proven ability to work with multi-disciplinary teams;
• Problem solving and trouble-shooting abilities.
Location:
Pudong District, Shanghai City / Changzhou City, Jiangsu Province

8、Director of Process Analytics Service (PAS)
Responsibilities:
• Master facilities operation of PAS, such as HPLC, GC, GC-MS, HPLC-MS, and ability to the daily maintenance.
• Familiar analysis mechanism and parts of facility.
• Strong analytical knowledge, understand relative laws and regulations, such as ICH, USP, Chinese Pharmacopoeia.
• As a team leader, leading the analytical research and creating reasonable plan.
• Responsible for many process analytics project and solve the problems independently.
• Make the conference meeting with client and give the project solution.
• Deliver all sorts of reports.
• Ensure effective training to team members.
• Coach team member to fulfill assigned the projects.
• Build and maintain the departmental SOP.
• Manage departmental IP, EHS and IP to compliance with company policy.
Qualifications:
• Pharmacology、chemistry、chemical engineering or analytical chemistry related Master or higher.
• Master chromatography and spectrophotometric analytical method as well as API physical and chemical analysis;Familiar with USP、EP and CP;Good knowledge and experience of cGMP.
• 7 years or more lab experience.
• Good ability of coordination and communication, and fluent English.
• Good ability of problem investigation and logical thinking.
• Following customer need,Guarantee smooth production.
• Ability to directing lower level employee management.
• Making timely determination in the organization.
Location:
Changzhou City, Jiangsu Province

9、Director, Oligonucleotide and/or Peptide Analysis
Responsibilities:
• Effective technical and project leadership in the analytical team with both R&D and Quality Control functionalities in support of the company’s oligonucleotide and/or oligonucleotide R&D and manufacture projects.
• As a key member for the oligonucleotide and/or oligonucleotide business unit, oversee daily operations in the analytical method development in R&D, as well as method validation and execution activities in GMP QC.
• Monitor quality, timelines, cost, and project progression.
• Ensure effective communication internally with process development team and manufacture team, and externally with clients regarding scientific findings in written or verbal English language, and host teleconference for corresponding discussion.
• Implementation of the company’s policies, quality systems and training programs. Follow the company’s code of conduct and compliance rules;
• Lead a group of analysts and quality control chemists
• Provide mentorship to the team members and conduct performance assessment

Qualifications:
• Advance degree in analytical chemistry, bioanalytical chemistry, pharmaceutical analysis or equivalent.
• Proven pharmaceutical industry experience (Master + 8 years or Ph.D.+5 years) in oligonucleotide analysis or close fields.
• Experience in analytical method development, validation, transfer and GMP compliance system.
• Hands-on experience in various analytical instrumentation (e.g. LC, GC, LC-MS, GC-MS, NMR)
Experience of oligonucleotide and/or oligonucleotide analytical method development and quality control is highly desirable.
• Strong communication skills in both written and verbal English language, and outstanding interpersonal skills are essential job requirements.

Location:
Changzhou City, Jiangsu Province

10、Director of Pre-formulation (PDS)
Responsibilities:
• Lead the Developability and Formulation Research organization within the PDS department; function as both an operation head as well as a technical lead
• Provide technical guidance to direct reports in planning, designing and coordinating the execution of protocols for developability assessment/pre-formulation studies/salt and polymorph/preclinical formulations
• Coordinate with the customer for new projects, preparing technical proposals addressing their needs and drawing up cost estimates for project work
• Review updates/ reports on ongoing projects to keep customers briefed on progress of projects
• Work closely with Department head to meet project timelines, departmental goal, and customer requests
• Plan for technological upgrades of the capabilities of the pre-formulation group by evaluating new technologies/instruments which can bring value to the customers and WuXi
• Contribute to budgeting process of pre-formulation part and ensure to operate within budget by maximizing efficiencies
• Hire and retain talents to meet the business needs
Qualifications:
• An accomplished individual with a Ph.D. degree in Physical Chemistry/Physical pharmacy or other related areas
• Experience and Knowledge: At least ten years of hands on working experience (after obtaining Ph. D. degree) and at least 5 years of experience in project/team management;
• Must have a demonstrated record of accomplishments in pre-formulation activities for solid and liquid oral dosage forms including developability assessment to discovery stage compounds. Formulation experience for other route of administration would be a plus
• Problem solving ability and adept handling of pre-formulation teams is a must-have quality. Experience of working across cultures would be an added benefit; Good communication skills, especially written and spoken both in Mandarin and English.
• Comply with all company policies and procedures.
Location:
Pudong District, Shanghai City

11. Director, Oligonucleotide Process Development and Manufacturing
Responsibilities:
Projects:
• Be able to lead one or more major collaborations.
• Be aware of all the requirements on all the projects such as priority, timeline and other special requirements from clients.
• Finalize the research plan and the execution program; ensure the team fully understand the whole plan and guideline to solve the issues during execution.
• Coordinate all the resource and make adjustment according to the progress and timeline on time.
• Immediately communicate with upper management and clients when issues to impact the progress and plan of the projects occur; and provide backup plan to ensure success of the project.
Management
• Be able to lead multiple groups simultaneously
• Be able to manage multiple projects simultaneously
• Be able to manage client’s projects dependently
• Organize all kinds of the trainings on the whole team to continuously improve the ability of the team
• Promote talented team members and evaluate on all the group leaders or team remembers
• Optimize the workflow and involve the daily management of the department
• Recruit new staff and provide trainings
• Ensure team members to strictly comply with all the policies of company and department. Daily Check lab safety, notebook and IP
• Ensure the personal safety of team members and the safety of labs. Investigate and prevent any violations and accidents.
Communication
• Communicate with clients efficiently by TC or email (carefully organize the materials and the detailed information)
• Ensure clients to be satisfied with our communications
• Ensure all the reports (including weekly update, final report , PPT file and campaign report) to be ready on time
• Response to clients immediately by TC or email for some special requirements.
• Assist to build good relationship with clients and to arrange visit for clients.
Qualifications:
• Master or PhD in chemistry, chemical engineering or equivalent degree.
• Expertise in process development and manufacturing of oligonucleotide drugs.
• Excellent in presentation and communication in English.
• 5 years or above experience (PhD) in process development and/or manufacturing of oligonucleotide drugs, 3 years or above projects management experience.
• 9 years or above experience (Master) in process development and/or manufacturing of oligonucleotide drugs, 5 years or above projects management experience.
• At least 5 years of people management experience.
• Strong project management and communication skills.
• Be able to build a highly productive and effective team, leads and motivates team to be efficient and innovative.

Location:
Changzhou City, Jiangsu Province

12. Director, Peptide Process Development and Manufacturing
Responsibilities:
Projects:
• Be able to lead one or more major collaborations.
• Be aware of all the requirements on all the projects such as priority, timeline and other special requirements from clients.
• Finalize the research plan and the execution program; ensure the team fully understand the whole plan and guideline to solve the issues during execution.
• Coordinate all the resource and make adjustment according to the progress and timeline on time.
• Immediately communicate with upper management and clients when issues to impact the progress and plan of the projects occur; and provide backup plan to ensure success of the project.
Management
• Be able to lead multiple groups simultaneously
• Be able to manage multiple projects simultaneously
• Be able to manage client’s projects dependently
• Organize all kinds of the trainings on the whole team to continuously improve the ability of the team
• Promote talented team members and evaluate on all the group leaders or team remembers
• Optimize the workflow and involve the daily management of the department
• Recruit new staff and provide trainings
• Ensure team members to strictly comply with all the policies of company and department. Daily Check lab safety, notebook and IP
• Ensure the personal safety of team members and the safety of labs. Investigate and prevent any violations and accidents.
Communication
• Communicate with clients efficiently by TC or email (carefully organize the materials and the detailed information)
• Ensure clients to be satisfied with our communications
• Ensure all the reports (including weekly update, final report , PPT file and campaign report) to be ready on time
• Response to clients immediately by TC or email for some special requirements.
• Assist to build good relationship with clients and to arrange visit for clients.
Qualifications:
• Master or PhD in chemistry, chemical engineering or equivalent degree.
• Expertise in process development and manufacturing of peptide drugs.
• Excellent in presentation and communication in English.
• 5 years or above experience (PhD) in process development and/or manufacturing of peptide drugs, 3 years or above projects management experience.
• 9 years or above experience (Master) in process development and/or manufacturing of peptide drugs, 5 years or above projects management experience.
• At least 5 years of people management experience.
• Strong project management and communication skills.
• Be able to build a highly productive and effective team, leads and motivates team to be efficient and innovative.

Location:
Changzhou City, Jiangsu Province

STA – US Based Positions

1.Process Research & Development Scientist
Responsibilities:
• The candidate will work within a team of process R&D scientist’s in conjunction with the Analytical Development Department and be co-responsible for developing, safe, efficient and easily scalable processes for producing starting materials, intermediates and active pharmaceutical ingredients (API’s).
• In addition, the candidate will assist in tech transfering projects to kilo lab, pilot plant, and plant scales and contribute to the safe and cGMP compliant execution of API manufacturing processes.
• The candidate will work with Quality Assurance to ensure that high quality standards are maintained and appropriate documentation such as process development and scale-up documentation including batch production records (BPR’s) are completed in a timely manner and that standard operating procedures (SOP’s) are written and followed.
• The ideal candidate will have shown proficiency in hands-on synthetic organic chemistry and the ability to solve process and scale-up problems through laboratory-scale investigations of organic synthesis reactions, separations, and milling processes.
Qualifications:
The position requires a strong background in process chemistry, as well as thorough knowledge of analytical techniques and understanding of cGMPs ICH and relevant FDA guidelines. CMO/CRO experience is beneficial.
Technical Skills / Knowledge:
• Significant experience in process development for small molecules.
• Experience in supporting all phases of API development, ideally spanning early development to registration.
• Demonstrated understanding of cGMP manufacturing for biopharmaceutical products.

Independence/ Accountability:
• Demonstrated success working effectively outside defined scope of responsibility, when required.
• Have a bias for action and display a sense of urgency.

Problem Solving:
• Provide technical and trouble-shooting support for process scale-up runs.

Communication Skills:
• Establish a good working relationship with peers to support and enable the delivery of intermediates/API in a timely fashion.
• Collate and present results in various forms, such as weekly/monthly reports, technical reports, and oral presentations for internal review and to management.

Customary Education and Experience:
• PhD in synthetic organic chemistry or related field with 3+ years of relevant experience, or equivalent combination of education (MS, BS) and industry experience.

Location:
San Diego, CA, USA

Contact person: gitty_wang@wuxiapptec.com