Clinical-stage Biopharma/Gene Therapy company focusing on rare and serious diseases
Greater Boston, MA area
Director/Senior Director, Analytical Development - Full time, permanent
This position will be part of the team that is developing the company's nano-particle technology platform, gene therapy candidates, and protein therapeutics that are in pre-clinical, early and late-stage clinical development.
This individual will play a critical and highly visible role within the company by leading the overall strategy and focus for the analytical team.
- PhD in a relevant, scientific field plus 10+ years of relevant experience
- Demonstrated leadership experience and expertise in biologics and small molecule analytical development
- Experience in a variety of analytical techniques
- Understanding of compendial methods, non-compendial test methods for batch release, product characterization, and control of impurities. Experience with characterization methods for product structure elucidation.
- Experience in CMC regulatory requirements and authoring CMC sections in support of INDs, BLAs.
If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details