List of Jobs


Multiple Positions

Status: Active
CompanyRVAC Medicines
LocationShanghai/Anji, China
Expiration2023-06-15
How to Apply

See https://rvacmed.com/Careers.aspx for details.

Manuf. Director, Drug Substance 

Responsibilities:

1. Setup key performance indicators of DS department according to global manufacturing and supply-chain goals, review them regularly and ensure that they are achieved.

2. Manufacture clinical samples and marketed products according to cGMP requirements, meet the needs of clinical and market demand in time, and with high quality.

3. Drive continuous improvement, to achieve operation excellence and lean manufacturing in DS.

4. Implement “quality by manufacture” culture in DS. Responsible for production-related quality investigations.

5. Responsible for team recruitment, personnel qualification training and talent retention in DS.

6. Own and responsible for field EHS in DS department.

7. Responsible for departmental budget and cost control.

8. Act as DP department head backup when needed.

Qualifications:

1. Master degree and above, 12y+ experience in bio-pharm industry.

2. 10y+ cGMP site manufacturing management experience.

3. Good communicator, team player and leadership skills required.

4. Accountable and diligent.

5. Fluent in English and Mandarin.

China AP/GL Supervisor

Responsibilities:

· Responsible for payment review and ensure compliance and consistence

1. Collect and review the supporting documents of payment requests, ensure compliance and accuracy

2. Reconcile hard copy supporting with PO and payment requests raised in OA system, ensure consistency

3. Reconcile payment record in OA system with bank statement by the end of each month, prepare bank reconciliation

4. Keep scanned copy for all payment supporting, prepare summary for final payment release

5. Track CAPEX commitments and payments

 

· Responsible for monthly book-keeping and tax filing

1. Timely and accurately book-keeping and voucher filing:

   a. Book transactions in line with OA payment record;

   b. Collect asset acceptance report before month end and timely book fixed assets; ensure consistency among book record, OA record and physical assets;

   c. Manage plant cost reconciliation and overhead allocation;

2. Issue monthly financial statements and account reconciliations for each legal entity;

3. Prepare monthly consolidation for all legal entities under China;

4. Prepare monthly global consolidation based on the input from US;

5. Track VAT invoices and responsible for monthly and annual tax filing for all legal entities in China

6. Conduct annual inventory and asset stock taking

 

Qualifications: 

1. Batchelor's degree in Accounting or Finance

2. At least 5 years’ working experiences in accounting, familiar with both PRC GAAP and IFRS, familiar with tax filing  and consolidation

3. Past working experiences in manufacturing plants is strongly preferred

4. Previous experience with start ups is strongly preferred

5. Flexibility to travel

6. Good communication skills, fluent in English

7. Familiar with word, excel & PPT; experience with Microsoft Dynamics is strongly preferred

8. Valid accounting certificate is a must, CPA/ ACCA is a plus

9. Detail driven, results driven and self-motivated.

Purchasing Supervisor-Operation

Responsibilities:

1. Manage the purchasing activities of Capex, production supplies, facility & equipment maintenance, Lab supplies, professional service, IT, T&E for RVAC in China. 

2. Contribute and Implement to the Sourcing strategy in above scope on procedures, give the input to develop the best practices with quality, cost, service and delivery objectives. 

3. Support Capex project in overall RVAC side.

4. Contribute or Implement to the supplier management programs for continuous improvement in Total Cost of Ownership (TCO).

5. Good understand of demand & supply, sourcing, contracting and budget tracking in Local market on production supplies, facility & equipment maintenance, Lab supplies.

6. Support the implementation of the Supplier Quality Standard program.

7. Coach internal user and stakeholders on general Procurement policies & Process.

8. Develop strong, ethical relationships with main suppliers and ensure that activities surrounding dealing with suppliers are under the good business practices and consistent with the RVAC Code of Ethics.

9. Draft and negotiate contracts, placing PO, spending tracking, manage supplier list, contract list for overall RVAC China as part of daily work.

10. Key measurements of success will be the consistence supply which include but not limited to supply base, on time delivery, quality, savings, service enhancement, lead time reduction and purchasing information maintenance.

11. Support Anji site with leveraged resource for a smooth startup until the Buyer in Anji accomplished the probation period.

12. Manage specific projects in RVAC per arrangement of the manager. 

Qualification:

1. Bachelor’s degree mainly on Chemical & Biopharma with 5-7 years of purchasing experience.

2. Experience with Raw material, Consumables & Reagent, facility operations in Biopharma, Medical or Chemical industry is a plus

3. Previous Experience working with Production, R&D in a regulated environment.

4. Experience of ERP system.

5. Strong communication, negotiation and contracting abilities are required.

6. Good influencing skills and Project management skills is a plus.

7. Strong technical purchasing skills in negotiation and contracting. Good problem-solving prioritization and conflict management skills.

8. Good team-worker. Strategic thinking with detailed working style. 

HRBP(Generalist)

Responsibilities:

1. Talent acquisition initiatives by following a recruitment process. Gearing employee hiring practices to organization’s development and expansion goals, the activities included: PRO vendor, Campus recruitment, Marketing outreach, Full recruitment cycle (job briefing, sourcing, interviewing, offering, background/reference check).

2. Facilitating communication between the company and existing, potential, as well as ex-employees including assist the townhall for classroom, conducting regular employee training sessions, observing employee relationships with each other and exit interviews etc.

3. Staying up to date with the labor regulations and make sure the organization is in compliance with them. The activities are supporting employees and the management with their issues; bridging the gap between employees and the management; promoting HR programs and creating a conflict-free workplace and developing, implementing, and modifying company/site policies.

4. Gathering useful HR metrics such as hiring time, employee turnover, employee satisfaction, reasons for turnover, employee outreach, and recruiting process perception and implementing and managing improvement systems.

5. Others may be assigned by line managers

Qualification:

1. 5+ years of experience in a human resource department

2. Excellent experience for full recruitment cycle, including campus and RPO service management

3. Good skill including communication skills, problem-solving skills, resourceful thinking, strong empathy and interpersonal skills

4. Willing to do attitude, faster learner and 100% integrity

5. Detail-oriented and attention to detail and analytically driven

6. Bachelor’s degree

7. English is a plus

Head of facility mgnt, (Sr.) Manager

Responsibilities:

1. Responsible for the day-to-day management of the engineering department to ensure the continuous and robust operations of a cGMP manufacturing facility with good EHS & regulatory compliance records.

2. Responsible for new construction, expansion and reconstruction of factories in Ajni. . Ensure project compliance with mRNA vaccine process and cGMP regulations.

3. Responsible for maintenance of facilities and equipment in accordance with cGMP requirements to ensure that facilities and equipment are always in good condition.

4. Responsible for the establishment, implementation, maintenance and continuous improvement of cGMP equipment management system

5. Responsible for equipment engineering related quality investigations.

6. Responsible for equipment IOQ validation, instrument calibration.

7. Responsible for site EHS related works and global regulatory compliance.

8. Responsible for departmental budget and cost control.

9. Responsible for personnel qualification training and team building.

Qualification:

1. Bachelor degree and above, 10y+ experience in pharm industry. Bio-pharm experiences is a plus.

2. New site setup experience needed.

3. GMP commercial manufacturing site facility maintenance experience required.

4. Good communicator, team player and leadership skills required.

5. Accountable and diligent.

6. ilingual languages required.

Director_mRNA Delivery and Formulation Sciences 

Responsibilities:

1. Oversee a team of scientists and evaluate mRNA delivery, and transition discovery programs for full-development activities and manufacturing. Provide technical mentorship to junior scientists

2. Provide technical guidance to improve performance of mRNA delivery systems through composition, process, and formulation optimization

3. Work cross-functionally to advance RVAC technologies that will include lipid-based delivery systems (including lipid nanoparticles)

4. Provide delivery-related support to platform and therapeutic programs

5. Analyze, interpret, and present data to internal and external audience using various formats including lab notebooks and meeting presentations

6. Prior management and mentorship experience; passion for people management and program development.

7. The ability to work cross culturally boundaries in a global environment.

8. Interface with Discovery, Manufacturing, Quality and Regulatory organizations

9. Lead the design and execute detailed experiments using risk assessments, appropriate scale down models, QbD principles, and process characterization/modeling techniques to develop and understand DPD processes.

10. Advance platform and functional initiatives through direct contributions and matrixed leadership

Qualifications:

1.  Education: PhD with 6-8years of experience, MS with 2+ years of experience, BS with 5 or more years of experience.

2. Education in Pharmaceutical Science, Molecular Biology, Analytical Chemistry, Biochemistry, or other relevant discipline

Scientist, Formulation

Responsibilities:

1. Act as a subject-matter expert for nucleic acid delivery technologies and provide key input on discovery and early development programs

2. Apply knowledge of nucleic acid delivery to prepare and characterize RNA and delivery vehicle including lipid nanoparticles.

3. Characterization and analysis of biophysical nanoparticle attributes

4. Provide formulations that support the final form and stability of RNA vaccines and therapeutics

5. Application of QbD principles and assessment of program/project risks that relate to delivery vehicle, formulations, process scale-up/scale-down, and work with GMP, Regulatory, and Quality to manage riskes  

6. Execute Informal stability studies on RNA-LNP product candidates

7. Think creatively to understand, trouble-shoot, and solve complex challenges, note program risks, and evaluate new technologies to ensure brilliant execution of function and program objectives.

Qualification

1. Working knowledge of non-viral nucleic acid delivery and key delivery vehicle platforms that include lipid nanoparticles, polymers, dendrimers, etc.

2. English fluency (written and spoken)

3. Strong capability with business software (Office 365 including, Teams, Outlook, Powerpoint, and excel)

4. Strong written and oral presentation abilities.  

5. Functional Understanding of Quality by Design (QbD) principles

6. Prior experience executing technical risk assessments (TRA) and tech transfer of a discovery/early development program to a GMP manufacturer (internal or external)

7. Track record of strong research contributions that could be demonstrated with first-authored publications in peer-reviewed scientific journals    

8. Education: PhD with 1-2 years of experience (Preferred), MS with 3+ years of experience, BS with 5 or more years of experience

9. 1-2 (minimum) or  2-5 years of experience (preferred) at an industrial research company or organization

10. Experience with non-viral delivery systems for nucleic acids.

      Preferred preparation of lipid nanoparticles and RNA or other nucleic acids 

Senior Supervisor, DP

Responsibilities:

1. 负责制剂车间日常管理,包括 EHS相关工作、部门预算和成本控制、以及部门人员资质培训和团队建设等,确保部门业绩持续稳定产出。

2. 负责与制剂生产相关的持续改进的实施,包括测试和验证。

3. 负责与制剂相关的 cGMP 生产管理体系的搭建、实施、维护和持续改进,包括制剂生产相关的质量调查等。

4. 负责临床样品、中试样品和商业化产品的生产,并为相关部门提供支持。

 

Qualifications:

1. College degree and above, 5yr+ experience in bio-pharm industry. 生物或药学相关专业大专及以上毕业,在生物领域从业5年以上。

2. 3yr+ cGMP site manufacturing management experience. 3年以上的 GMP药厂的生产管理工作经验。

3. Good communicator, team player and leadership skills required. 擅长于交流和团队合作,具备领导力技巧。

4. Accountable and diligent. 踏实有责任心,工作细致认真。

Expert, DS&DP technology 

Responsibilities:

1. Key accountabilities include but not limited t

2. Technical transfer among R&D department, manufacture sites in China and other facilities within RVAC organization, as well as to & from CDMOs of RVAC’s choice.

3. Studies of process scaling up, optimization and comparability.

4. Provide technical guidance to reports and cross functional asset teams in areas of process tech transfer, process design and scale-up, facility fit, gap analysis. FMEA risk assessment, trouble shooting and investigation.

5. By cooperation with manufacture team, perform process validation as well as PPQ runs to make sure technology can be transferred successfully for clinical & commercial manufacturing.

6. Provide technical support to investigation of deviations during GMP batches and generating CAPA plans with QA and manufacture teams.

7. Dossier writing/reviewing to support IND/NDA applications and works as a Subject Matter Expert during internal and externa audits during projects.

8. Drive innovation and continuous improvement towards cost & efficiency.

 

Qualifications:

1. Bachelor’s degree and above

2. MNC working experience or well-known companies required. Comfortable working in a global network and using English as working language.

3. Good communicator, team player with influence skills

4. Accountable and diligent

Technician, DS&DP- mSAT

Responsibilities:

1. Technical transfer among R&D department, manufacture sites in China and other facilities within RVAC organization, as well as to & from CDMOs of RVAC’s choice.

2. Studies of process scaling up, optimization and comparability.

3. Cross functional asset teams in areas of process tech transfer, process design and scale-up, facility fit, gap analysis. FMEA risk assessment, trouble shooting and investigation.

4. By cooperation with manufacture team, perform process validation as well as PPQ runs to make sure technology can be transferred successfully for clinical & commercial manufacturing.

5. Provide technical support to investigation of deviations during GMP batches and generating CAPA plans with QA and manufacture teams.

6. Dossier writing to support IND/NDA applications.

7. Drive innovation and continuous improvement towards cost & efficiency.

 

Qualifications:

1. Bachelor’s degree and above major in biotechnology and relevant

2. Comfortable working in a global network and using English as working language.

3. Good communicator,

4. Accountable and diligent

(Sr.) Scientist - Principle Scientist, Immunology 

 

Responsibilities:

1. Search and read relevant literature to generate target hypothesis and make proposals.

2. Design, construct, and test expression and activity of vaccines in a variety of assays.

3. Build and conduct in vitro experiments to investigate target mechanisms of action

4. Work as part of a multi-disciplinary scientific team to implement experimental plans and achieve project goals .

5. Supervise and communicate results of experiments with CROs  for  Animal study.

Qualifications:

1.Ph.D. in Immunology or a related field with 3 years industry experience.

2.Proficiency in Immunology skills, such as invitro and invivo validation, including: Pseudovirus-based neutralization, T cell assay and ELISpot.

3. Excellent track record of scientific experiences as demonstrated by publications, patents, or awards.

4.  Experience with vaccine study design.

5.  Experience with Immunology.

6.  Experience with assay development or binding assay .

7.  Experience with experiment design and data analysis.

8. Must be very well-organized and be able to handle multiple projects simultaneously.

9. Must be a quick learner who is self-motivated and able to ask novel questions and seek clarity.

10. Must be flexible with day-to-day duties and able to thrive in a start-up environment.

11. Must be an excellent team member with strong communication skills and a desire to work collaboratively.

12. Must hold him or herself to the highest professional, scientific and ethical standards 

Scientist, Virology

Responsibilities:

1. Participate in design and optimization of exploratory experiment in virology and immunology field

2. Conduct molecular, cellular, and virology experiments to support preclinical proof-of-concept studies

3. Record the data completely, accurately, and timely. Comply with the SOP and regulations of bio-safety laboratory

4. Efficiently communicate scientific data within the company

 

Qualification:

1. M.S. in life science and at least 2 years of relevant experience in pharmaceutical industry is required.

2. Hands-on experience including maintenance of continuous mammalian cell cultures, plasmid extraction, in vitro transcription, virus stock production, virus isolation, viral plaque assays, qPCR, ELISA, WB, ELISPOT, flow cytometry, and other standard viral and immunological assays.

3. Experience in handling small lab animals is preferred.

4. Self-motivated, ability to work independently as well as part of a team effort.

Senior Scientist, Virology

Job Responsibilities:

1. Build virology research lab to support development of RNA-based novel medicines for various disease indications

2. Design and execute molecular, cellular, and virology experiments. Preclinical proof-of-concept studies

3. Author study reports, manuscripts for publication, and technical sections in patent application documents

4. Participate in design and optimization of exploratory experiment in virology and immunology field

5. Efficiently communicate scientific data within the company

 

Qualification:

1. Ph.D. in life science and at least 4 years of lab-based research experience is required.

2. Hands-on experience with various cell biology, immunology, virology techniques including but not limited to maintenance of continuous mammalian cell cultures, plaque assay, TCID50 assay, fluorescence microscopy, virus stock production, virus isolation, viral plaque assays, hemagglutination, PCR, ELISA, ELISPOT, flow cytometry, and other standard viral and immunological assays.

3. Broad breath of understanding across virology, cell biology, immunology/vaccinology, molecular biology, microbial pathogenesis.

4. Demonstrated ability to think innovatively, creatively, and strategically and to exercise sound scientific and business judgment.

5.  Knowledge of viral genomics and bioinformatics tools and resources is highly preferred.

6. Excellent written and verbal communication skills, including excellent listening skills and presentation skills to communicate clearly, concisely, and effectively.

7. Self-motivated, ability to work independently as well as part of a team effort.

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