Associate Director, Process Development
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for chemical development and CMC-related aspects of chemical development involving clinical development programs in Phase 2, Phase 3 (including validation activities) and commercial programs. He/she/they will participate on the CMC project teams and collaborate closely with other functions including analytical and formulation development, non-clinical development, process development, quality, regulatory, and supply chain to support later stage development programs and support validation and commercialization activities.
Roles and Responsibilities
- Oversees process development planning and execution for clinical phases including route development, process scale up, particle control, developing starting material and impurity control strategies, process validation and associated activities and manufacture of GMP drug substance.
- Actively contributes to IP / patent related activities.
- Partners closely with other functions including analytical and formulation development, non-clinical development, process development, quality, regulatory and supply chain.
- Participates on CMC teams and oversees execution of chemical development activities at external contract research organizations and manufacturing facilities.
- Authors and reviews drug substance related sections of regulatory filings.
- Drives to achieve the best development and business results for SAGE across all stages of development.
- Other tasks as assigned or as required for a given program.
Experience, Education and Specialized Knowledge and Skills
The successful candidate has a proven track record in chemical development for clinical stage programs and process validation. In addition, the candidate has a broad understanding of pharmaceutical development and CMC related activities, including process analytical development and formulation development. Excellent leadership, communication and collaboration skills in a cross-functional and fast paced environment as well as a proven ability to achieve results in a virtual setting with external contract research organizations and manufacturing facilities are a must. Other requirements are:
- BS Degree in Organic Chemistry
- 7+ years relevant small molecule chemical development, scale up and CMC experience in the pharmaceutical industry
- Advanced degree in Organic Chemistry, PhD preferred
- Demonstrated ability to manage outsourced process development and manufacturing activities in a virtual environment both domestically and internationally
- Strong problem-solving skills and ability to multitask and succeed in a fast-moving and dynamic environment.
- Excellent verbal and written communication skills, ability to effectively work across levels, functions and companies
- Ability to travel up to 30% as allowed
- Experience in writing regulatory documents and submissions
- Direct experience in process validation and authoring CMC sections of NDAs strongly preferred.
- Quality and project management experience is a plus
- Embraces our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of SAGE