VP, Chemistry Manufacturing and Controls (CMC)
Skills
- Strong leadership and team management skills.
- Expertise in drug substance and drug product manufacturing process development.
- Knowledge of FDA and EMA regulatory frameworks related to CMC.
- Experience in process scale-up and validation under cGMP conditions.
- Skilled in preparing regulatory submissions and managing inspections.
- Proven project management and communication abilities.
- Analytical and organizational skills with innovative problem-solving.
Responsibilities
- Develop and implement CMC strategy aligned with company goals.
- Lead and manage the CMC team fostering quality and innovation.
- Oversee small molecule drug substance and product manufacturing process development.
- Ensure successful scale-up from lab to clinical and commercial production.
- Lead chemical process development, formulation, analytical methods, validation, and supply activities.
- Ensure full compliance with FDA, EMA, and industry regulations.
- Prepare and submit regulatory filings including INDs and NDAs.
- Manage timely and cost-effective clinical and commercial supply production.
- Collaborate with Quality Assurance for product quality and compliance systems.
- Coordinate cross-departmental collaboration on CMC initiatives.
- Manage CMC budget and resource allocation.
- Recruit, mentor, and develop CMC team members.
- Maintain inspection readiness with Quality Assurance and Regulatory Affairs.
- Lead project teams contributing to product development strategies.
Education
- Advanced degree (Ph.D. or M.S.) in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, or related scientific discipline.
Benefits
- Opportunity to lead a pivotal function in a cutting-edge clinical-stage biotech.
- Collaborative and innovative working environment.
- Professional growth and development opportunities.
- Inclusive workplace embracing diversity and equal opportunity.
Average salary estimate
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