General Scope and Summary
This position provides an opportunity to join the growing Sage Technical Operations group and contribute 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 Analytical Development group as well as other members of the Technical Operations and Quality Assurance teams.
Roles and Responsibilities
- Manage analytical activities conducted at third party labs including stability studies, release testing of drug substance and drug products and reference standards qualification.
- Provide data for regulatory filings.
- Actively communicate, and collaborate with colleagues and third party vendors to ensure optimal execution and high quality of records of analytical activities
Experience, Education and Specialized Knowledge and Skills
The successful candidate understands analytical sciences and regulatory/GMP requirements, and has experience in analytical development/QC environment for different clinical stage and/or commercial programs. He/she 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:
- Technical background in Chemistry, Analytical Chemistry or related field
- 5+ years of relevant small molecule analytical development/quality control experience in the pharmaceutical industry and/or equivalent experience
- Practical experience with a broad range of analytical techniques
- Proven track record in managing analytical / QC activities in advanced clinical stages and/or for commercial products
- Experience in Quality Assurance is a plus
- Detail oriented; hands on problem solving skills
- Excellent organizational and documentation skills
- Excellent verbal and written communication skills
- Thorough working knowledge of GMPs, ICH and relevant FDA guidelines
- 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