Sr. Director/Director, Early Development CMC, Biologics
Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company with a Research & Development (“R&D”) innovation engine that aims to discover, develop, and ultimately deliver impactful medicines to patients. Our programs span discovery-stage to late-stage development and cover a range of high-value indications in rare diseases and immuno-oncology. We are led by a management team with extensive R&D experience from leading biotech and pharmaceutical companies. We are focused on rapidly advancing our product candidates from research through all stages of development leveraging our differentiated R&D model. This model is designed to harness the key strengths of a traditional R&D organization and the core tenets of an asset-centric venture capital model to optimize deployment of funds for discovery and development.
Centessa continues to expand its CMC group and currently seeks a (Sr.) Director Early Development CMC, Biologics. The (Sr.) Director will be responsible for guiding early stage CMC process development and specifically purification processes for recombinant proteins. The successful candidate will have hands on experience in the Biological NME early stage development in support, specifically pre-clinical through phase II . This person will oversee work with various vendors to deliver drug product to the program teams. Travel to vendors both domestically and internationally will be required, no greater than 20%. Remote working at other times is possible.
- Demonstrated broad knowledge of biologics manufacturing processes, including cell culture and purification operations, and knowledge of process development from early development
- Experience leading biologics manufacturing early biological process development activities, including process characterization studies, process scale-up, and technology transfer.
- Development of phase appropriate formulation, labeling and packaging
- Demonstrated knowledge scientific and regulatory requirements and strategy for early phases of development and support of regulatory filings.
- Act as CMC Developmental Contact for programs still in Discovery
- MS or Ph.D. in chemistry, pharmaceutical sciences, or related field preferred
- 15+ years of industry experience in biologics, working in early to mid-development (phase I-phase II)
- Experience in purification methodologies and their development
- Must live in Eastern or Central time zone
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.