(Sr.) Director, CMC Biologics
The mission of Centessa Pharmaceuticals plc (Nasdaq: CNTA) is to deliver consequential new medicines to patients. The Centessa family includes wholly owned, highly specialized companies, with drug discovery and development programs in diverse therapeutic areas. The company’s organizational structure and approach combine the agility and sense of urgency typical of start-up companies with the scale and diversification typical of larger R&D organizations.
Centessa continues to expand its CMC group and currently seeks a (Sr.) Director of CMC, Biologics. The successful candidate will have hands on experience in the Biological NME late-stage development and commercial product management and be able to develop the approval and launch strategies. This person will oversee work with various vendors and oversee an internal logics function as it is development. Travel to vendors both domestically and internationally will be required.
- Provide technical and management oversight to vendors development new molecular candidates, specifically in preparation for pivotal studies and launch. The focus will be on development or refinement of manufacturing processes, as well as fully characterization and validation of processes and testing methods; this includes Drug Substance, Drug Product and packaging & Labeling
- Act as the CMC core team member in cross functional developmental teams for late-stage projects.
- Accountable for CMC aspects of regulatory filings.
- Responsible for helping to build out a logistics organization
- Assistance in batch record review
- Assistance in deviation investigations
- Thorough understanding of cGMP requirements for pharmaceutical products
- Strong organizational, analytical and interpersonal skills
- Ability to work independently in a fast-paced dynamic environment with multiple projects
- Demonstrated ability to coordinate CMO activities in the development and commercialization of pharmaceutical products
- Strong decision-making and analytical skills
- Excellent organizational skills, project management skills and detail-orientated leadership approach
- Must be willing to travel both domestically and internationally
- Minimum of a B.S. degree in biology, chemistry, pharmaceutical sciences, or related field
- 15 years of industry experience in biologics, working in early-stage development through product launch
- Experience in sterile fill/finish of drug product preferred.
- Experience in Supply Chain requirements and timing (packaging/labeling is a plus but not mandatory as well as a deep understanding of GMP regulations)
- Requires a strong understanding of managing groups, CMOs, CDMOs and other vendors
POSITION: Full-Time, Exempt, Flexibility for Remote Work
EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.