CMC Stability Coordinator at Biopharmaceutical Company in Boston, Massachusetts, United States —
- bio Pharmaceutical
- Biopharmaceutical Company
- Boston, Massachusetts, United States USA
- 1/19/21 2021-01-19
Job ID: 1361367
- Review all stability data /reports and update stability tables accordingly
- Perform trending analysis of stability data and facilitate timely investigation of OOT & OOS occurrences
- Compile and write Annual Product Reviews for products, as necessary
- Support drafting of stability updates for regulatory filings including IND’s and IND annual reports
- Provide support to coordinate completion of technical reports through contract research organizations (CRO’s) and contract development and manufacturing organizations (CDMO’s)
- Draft drug substance and drug product specifications and obtain signatures for approval
- Review and document test methods, batch records, stability protocols, method validation protocols and reports
- Bachelor's degree in a scientific discipline. Master's degree preferred
- 3 - 5 years pharmaceutical industry experience in Analytical Development, Quality Control or Quality Assurance
- High proficiency with MS Excel & Word necessary
- Participation in regulatory agency inspections and experience with document management systems and Slimstat® shelf-life projection software a plus.
- Previous experience working with pharmaceutical vendors / collaborators highly preferred
- Excellent written and oral communication skills, with the ability to communicate complex information allowing for an open and effective dialogue throughout the company.
- Strong organizational skills with the ability to effectively multi-task and prioritize
- Ability to flexibly adapt to changing business needs and meet timelines
- Ability to analyze & interpret stability data
- Strong attention to detail and quality are critical to success
- Resourceful, self-starter and team player with a strong results orientation
- Able to command respect from peers and capable of highly independent work as well as being a team player and role model.
- Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
- Proven ability to manage multiple projects, identify and resolve issues.
- Broad experience in a small company environment is a plus