General Scope and Summary
SAGE Therapeutics is searching for a technical leader for a highly visible role as Sr. Director Process Development. The successful candidate will be responsible for developing manufacturing processes from phase 3 through commercial validation, and for supporting technology transfers and drug product validations. The successful candidate will lead technical teams and collaborate closely with other functions including pharmaceutical development, analytical development, commercial manufacturing and supply chain to advance Sage’s fast growing portfolio of products.
Roles and Responsibilities
- Plans and oversees manufacturing process development and technology transfer activities at third party laboratories and facilities from phase 3 through commercial validation
- Is responsible for the phase -appropriate relevant sections of IND/NDA’s and other regulatory filings
- Works closely and supports other functions including pharmaceutical development, analytical development, commercial manufacturing and supply chain to advance SAGE’s fast growing pipeline
- Leads technical development teams, e.g. tech transfer teams or CMC teams
- Actively contributes to CMC teams, and ensures alignment of process development and tech transfer activities with CMC and program development plans
- Actively communicates, collaborates with and contributes to other functional areas and drives to achieve the best development and business results of the company
Experience, Education and Specialized Knowledge and Skills
The successful candidate has a broad understanding of chemical process and analytical development, and a proven track record solving complex technical and scientific issues. Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent leadership, communication and collaboration skills in a cross-functional, multi-faceted environment; as well as a proven ability to achieve results in a virtual setting with external laboratories and manufacturing facilities are a must. Other requirements are:
- Advanced degree in Chemistry, Chemical Engineering or related field, Ph.D. preferred
- 10+ years relevant chemical process development experience in the pharmaceutical industry, drug product development experience is preferred
- Strategic view and leadership abilities as well as hands on problem solving skills
- Excellent verbal and written communication skills, ability to effectively work across levels, functions and companies (up to 30% travel)
- Experience in writing regulatory documents and submissions
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- 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