Stability Manager
- Job Title
- Stability Manager
- Job ID
- 27698730
- Work Hybrid
- Yes
- Location
- Boston, MA 02108
- Other Location
- Description
-
Description:
The Stability coordinator position is primarily responsible for managing all stability studies for clinical development candidates and commercial materials in AVEO’s product portfolio.
The incumbent will manage the day to day activities of the stability programs including stability protocol review and approval, data and review and trending and working stability study groups at the contract laboratories.
The incumbent will also be accountable for management of the AVEO reference standard program.
The ideal candidate has significant hands on experience in performing and managing stability studies in a regulated environment
Responsibilities- Coordinate and oversee outsourced stability studies
- Review and approve stability protocol, track testing, review and trend stability data.
- Coordinate the review and approval of stability reports
- Responsible for the upkeep of all stability related documents
- Assure that all aspects of stability operations comply with applicable SOPs.
- Work with partners and CMOs to ensure that reference standards and materials are appropriately managed and requalified.
- Requires a BS/BA. in Chemistry, Biochemistry or equivalent scientific discipline
- 3-5 years experience in performing/managing stability studies in a pharmaceutical / biopharmaceutical laboratory under regulated environment
- Familiarity with cGMP, USP/EP, and FDA/EMEA regulations for biopharmaceutical products
- Knowledgeable in the analytical methodologies utilized for small molecules and/or monoclonal antibodies for early clinical through late stage/commercial manufacturing
- Written and verbal communication skills
- Excellent document preparation and review skills
- Experience using computer-based statistical analysis and data reporting, and trending packages a plus
- Proficiencies with Microsoft Office and associated applications
- Attention to detail and the ability to work independently and as part of a dynamic team environment with minimal supervision.
