Our clinical-stage vaccine client located in Boston, MA is growing and looking to add at Stability Coordinator to their Tech Ops team! This role will act as the single point of contact for Analytical Development (AD) and Manufacturing Sciences and Technologies (MS&T), coordinating with various internal and external groups to enable stability and reference material related activities. Responsibilities include but not limited to:
- Generation and review of stability protocols and reports.
- Monitoring of stability due dates and coordination of testing and data transfer with vendors.
- Review of stability data, generation of stability result tables, and filing of stability data and results tables.
- Oversight of the qualification, inventory, and supply of reference standards.
- Coordination of all domestic and international stability sample and reference standard shipments.
- Supporting the CMC team in the filing of documents, particularly drafting and reviewing stability and analytical sections of IMPD/NDA or related regulatory dossiers.
- B.S. degree in Chemistry, Biology, or other relevant field and have at least 2 years coordinating stability and reference standard programs in the pharmaceutical or related industry.
- Candidates should have detailed knowledge of ICH stability guidelines, current Good Manufacturing Practices (CGMP), compendial (USP, EP, JP, etc.) requirements and standards for QC testing.
- The successful candidate will have excellent organizational skills and attention to detail, as well as strong interpersonal and communication skills to collaborate effectively with internal and external business partners.
- The candidate should be a self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a structured GMP testing environment.