General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for contributing substantially to the successful characterization, scale up, and manufacturing of novel CNS medications. As a key member of the Technical Operations group, the successful candidate will work closely with the Senior Director, Pharmaceutical Development and the Director, Analytical Development as well as other members of the Technical Operations team.
Roles and Responsibilities
- Responsible for managing analytical development and related activities for clinical phase development programs in order to advance Sage’s fast growing portfolio of products.
- Partner with Quality Assurance and Regulatory Affairs to ensure that high quality standards are maintained and the appropriate documentation is completed.
- Demonstrated proficiency in both hands-on analytical work, the ability to manage activities and solve analytical challenges at third party pharmaceutical manufacturers, and extensive experience reviewing and organizing analytical data
- Manage analytical activities conducted at third party labs including method development and validation, stability studies, release testing of drug substance and drug products and reference standards.
- Provide input and data for regulatory filings.
- Actively participate in the design of specifications in alignment with control strategies in a changing developmental environment for drug substance and drug product
- Actively communicate, and collaborate with colleagues and third party vendors to ensure optimal execution and record of analytical activities
- The successful candidate has a broad understanding of analytical sciences and regulatory/GMP requirements, and a proven track record in analytical development for different clinical stage and commercial programs. Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent 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 laboratories and manufacturing facilities are a must. Other requirements are:
- Experience, Education and Specialized Knowledge and Skills
- Advanced degree in Chemistry, Chemical Engineering or related field, PhD preferred
- 8+ years of relevant small molecule analytical experience in the pharmaceutical industry
- Requires a strong background in Analytical Development, and expertise in separation techniques, as well as a thorough knowledge of cGMPs, ICH and relevant FDA guidelines.
- Practical experience with a broad range of analytical techniques, charged aerosol detection and/or, microbiological experience is a plus
- Proven track record in managing analytical aspects of development programs in advanced clinical stages