CMC Manager
Descrizione dell'offerta
CMC Manager – Cell & Gene Therapy
A leading biomedical research organization dedicated to advancing transformative treatments for rare genetic disorders is seeking an experienced CMC Manager to join its growing Cell & Gene Therapy team.
This is a strategic and hands-on leadership role responsible for driving Chemistry, Manufacturing & Controls (CMC) activities across advanced therapy programs from early development through commercialization.
The Role
As the CMC Manager, you will own and execute the CMC strategy for assigned programs, ensuring scientific integrity, regulatory compliance, and high-quality delivery throughout the product lifecycle. You will collaborate across internal functions and external manufacturing partners to enable successful discovery, clinical and commercial outcomes.
You will play a key role in managing risk, ensuring product quality, safeguarding patient safety, and maintaining regulatory alignment while driving development timelines forward.
Key Responsibilities
- Define and implement CMC strategy, incorporating Quality by Design (QbD) principles
- Lead and support regulatory CMC documentation (IND, IMPD, BLA, MAA submissions)
- Develop and maintain control strategies, stability programs, and comparability plans
- Assess regulatory impact of manufacturing and analytical changes
- Oversee process development, optimization, scale-up, and technology transfer in GMP settings
- Coordinate manufacturing activities for clinical trial supply and support commercial readiness
- Develop raw materials strategy including supplier qualification, traceability, and risk mitigation
- Collaborate cross-functionally with Quality, Regulatory Affairs, Clinical, Supply Chain, and CDMOs
- Support quality investigations and structured risk management activities (ICH Q9, FMEA)
- Contribute to CMC planning, milestone tracking, and overall program execution
Profile:
Education & Experience
- Degree in Chemistry, Pharmacy, Chemical Engineering, Biotechnology, or related scientific discipline (PhD preferred)
- 7–8+ years of CMC experience within pharmaceutical or biotech environments
Technical Expertise
- Strong knowledge of ICH Q9, Q10, Q11, and M4(R2)
- Experience with Quality by Design (QbD)
- Structured risk management (FMEA)
- Technology transfer and process scale-up
- Analytical method validation
- CMC comparability strategies
- Fluency in English
Highly Desirable
- Experience in nucleic acid-based manufacturing (e.g., mRNA, siRNA, plasmid DNA drug product)
Key Competencies
- Strategic and systems-level thinking
- Strong analytical and problem-solving skills
- Effective decision-making with clear risk assessment
- Ability to operate in cross-functional, matrixed environments
- Excellent communication and stakeholder management skills