上海招聘CMC senior director（制剂背景）

医药荐客 2022-01-04

Role Title:CMC, Sr. Director

Reporting to: Functionally report to VP, Head of CMC （外国人，在美国）

Direct Reports: 0-30 (Depends on the next step plan , if we build lap, we can establish an in-house CMC team)

Working Location: Shanghai

核心要求：博士，10年以上经验，特别是新药制剂开发，英语流利

Role Purpose Statement:

The incumbent will execute company’s CMC strategic goal and vision, optimize the team infrastructure and process, accomplish missions from internal and external stakeholders.

Main Accountabilities:

1. Build, manage and lead the CMC Team and Lab in China for drug substances and drug products.

2. Develop and implement comprehensive strategies to manufacture drug substance / drug product, and assume all aspects of process / analytical development, manufacturing, and quality control.

3. Lead CRO / CMO strategy including selection and contract negotiation, ongoing troubleshooting, data analysis and interpretation.

4. Work across functional groups in identifying issues that may delay timelines, providing solutions to difficult technical/functional issues associated with specific projects, as well as support the resolution of issues that arise.

5. Maintaining program-related CMC-specific documentation, including, but not limited to, program plans, timelines, and budget

6. Serve as the CMC project leader for assigned Drug Products if needed.

7. Lead the process development of monoclonal antibody/SME drugs, technology transfer, pilot amplification, including development planning, management of the entire process of CMC Development, and ensure it align with the overall project plan.

8. Responsible for the production of samples for early clinical research of innovative drug; process amplification, quality control optimization and process validation in clinical research stage; technology transfer with production and quality management department before clinical sample production;

9. Provide CMC inputs/ evaluation to BD team on the new products and new patents license-in.

10. Provide Inputs to drug discovery team on the drugability of new products;

11. Maintain effective communication with internal and external responsible parties.

12. Define the CMC activities required for implementation of the product clinical/commercial plan, ensure alignment with company’s overall business strategy.

13. Develop the Product Definition and CMC Strategy documents with appropriate input from cross-functional team members

14. Direct/oversee contract manufacturing, testing, packaging and labeling operations for the company’s drug substances and drug products. Act as primary liaison with contractor(s) on assigned projects. Guide external operations through tech transfer, process and method development, optimization, qualification and validation of the activities related to all manufacturing operations.

15. Proactively identifying knowledge gaps and risks, and work with the teams and team leaders to develop mitigation plans.

16. Monitor and control the CMC process; within budget, and timeline.

17. Provide support for process optimization,production improvement and cost control of products;

18. Provide support and suggestions for plant design and equipment selection;

19. Working with Quality Assurance, develop SOPs and guidelines related to the production, planning, disposition and management, materials, etc.

20. Design and execute the development plan to support global submissions.

21. Prepare CMC regulatory filing sections (domestic and international) working with Regulatory and Quality

22. Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required

23. Develop production plans to support preclinical, clinical, and commercial development and adjust plans as appropriate to meet corporate objectives

24. Provides comprehensive project analysis to senior management as required in the form of reports or presentations as needed

25. Maintain knowledge of current best practices of manufacturing. Identify emerging trends and technologies and lead implementation/feasibility assessment, as appropriate

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education/Experience: The ideal candidate will offer:

1. Overseas. PhD preferred in a relevant area of study, with a minimum of 10 years of relevant experience in pharmaceutical GMP development and process chemistry.

2. A minimum of 10 years of experience in CMC project management, development, scale-up and clinical/commercial development and manufacturing in the biotechnology or pharmaceutical industry

3. Strong foundation in chemistry, materials science, pharmaceutical sciences or chemical engineering required.

4. Strong background in modern synthetic organic chemistry and drug development processes required.

5. Experience in leading and direct management of research, process development, and manufacturing

6. Extensive experience in leading biological process and analytical development

7. Experience in achieving regulatory approval of new drugs or biologicals

Knowledge, Skills and Abilities:

1. Familiar with the latest regulations and rules of CFDA,NMPA.

2. Good understanding of cGMP regulations and guidelines relating to CMC-related areas

3. Knowledge of global CMC-related regulatory requirements and guidelines an advantage

4. Excellent leadership, managerial and communications skills in a cross-functional environment

5. Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissions

6. Prepared and managed the preparation of CMC regulatory filings

7. Ability to provide hands-on problem-solving skills and strong critical thinking.

8. Excellent communication skill in English.

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