CMC生产管理负责人
发布于： 07/08/2026
Shanghai or Jiangsu East China
Permanent
生命科学、医疗保健、制药
Drug Product & Analytical Development
Position Summary
This position will provide scientific and strategic leadership for late-stage pharmaceutical development. This role requires a variety of skills and experience. Some experience with each of the following is a plus: Discovery support, drug substance development, drug product development, analytical development (method development, tech transfer, and validation). The candidate will be responsible for leading all phases of product development from discovery support, drug product development, analytical development, technology transfer, process validation, regulatory submissions, and commercial launch readiness activities. The successful candidate will work cross-functionally with Regulatory Affairs, Quality, Supply Chain, and external partners to advance products from early development through commercialization.
Key Responsibilities
Drug Product Development
Lead formulation and process development activities for various stages of clinical and commercial products.
Develop and execute scale-up, technology transfer, and process validation strategies.
Oversee PPQ and commercial process readiness activities.
Analytical Development
Direct analytical method development, qualification, validation, and transfer activities.
Establish analytical control strategies and commercial specifications.
Oversee stability programs and support shelf-life determination.
Ensure analytical methods comply with current regulatory expectations.
Regulatory Support
Review CMC sections of INDs, NDAs, BLAs, MAAs, and lifecycle submissions.
Lead responses to health authority requests and deficiency letters.
Support regulatory inspections and pre-approval inspections.
Program Leadership
Manage external development and manufacturing partners.
Promote a high-performance culture focused on quality, innovation, and execution.
Manage departmental resources, budgets, and priorities.
Qualifications
Required
Ph.D. with 8+ years, M.S. with 10+ years, or B.S. with 12+ years of pharmaceutical industry experience.
Minimum 3 years of project leadership experience.
Experience in drug product and analytical development within regulated pharmaceutical environments.
Experience with both early and late phase product development.
Strong knowledge of GMP, ICH, and global health authorityrequirements (FDA, EMA, PMDA, etc.).
Experience with technology transfer, process validation, analytical method validation, and responses to healthy authority requests.
Excellent communication and stakeholder management skills.
Candidate must be fluent in both Mandarin Chinese and English (spoken and written).
Preferred
Experience leading products through regulatory approval and commercial launch.
Experience with managing CDMO networks.
Prior participation in FDA, EMA, PMDA inspections or similar.
Experience with QbD, control strategy development, and lifecycle management.
Position Summary
This position will provide scientific and strategic leadership for late-stage pharmaceutical development. This role requires a variety of skills and experience. Some experience with each of the following is a plus: Discovery support, drug substance development, drug product development, analytical development (method development, tech transfer, and validation). The candidate will be responsible for leading all phases of product development from discovery support, drug product development, analytical development, technology transfer, process validation, regulatory submissions, and commercial launch readiness activities. The successful candidate will work cross-functionally with Regulatory Affairs, Quality, Supply Chain, and external partners to advance products from early development through commercialization.
Key Responsibilities
Drug Product Development
Lead formulation and process development activities for various stages of clinical and commercial products.
Develop and execute scale-up, technology transfer, and process validation strategies.
Oversee PPQ and commercial process readiness activities.
Analytical Development
Direct analytical method development, qualification, validation, and transfer activities.
Establish analytical control strategies and commercial specifications.
Oversee stability programs and support shelf-life determination.
Ensure analytical methods comply with current regulatory expectations.
Regulatory Support
Review CMC sections of INDs, NDAs, BLAs, MAAs, and lifecycle submissions.
Lead responses to health authority requests and deficiency letters.
Support regulatory inspections and pre-approval inspections.
Program Leadership
Manage external development and manufacturing partners.
Promote a high-performance culture focused on quality, innovation, and execution.
Manage departmental resources, budgets, and priorities.
Qualifications
Required
Ph.D. with 8+ years, M.S. with 10+ years, or B.S. with 12+ years of pharmaceutical industry experience.
Minimum 3 years of project leadership experience.
Experience in drug product and analytical development within regulated pharmaceutical environments.
Experience with both early and late phase product development.
Strong knowledge of GMP, ICH, and global health authorityrequirements (FDA, EMA, PMDA, etc.).
Experience with technology transfer, process validation, analytical method validation, and responses to healthy authority requests.
Excellent communication and stakeholder management skills.
Candidate must be fluent in both Mandarin Chinese and English (spoken and written).
Preferred
Experience leading products through regulatory approval and commercial launch.
Experience with managing CDMO networks.
Prior participation in FDA, EMA, PMDA inspections or similar.
Experience with QbD, control strategy development, and lifecycle management.