Quality Control Scientist
The Quality Control Scientist will provide oversight of contract analytical labs and manufacturers. This includes, review of analytical data from release and stability studies and review of method validation protocols and reports. The candidate should have a strong understanding of cGMPs and relevant ICH and FDA regulatory guidelines. Prior hand-on experience working in a QC lab and with root cause analysis for investigations is required. This position will interact and work closely with cross-functional teams, including, manufacturing, quality assurance and regulatory.
- Review analytical data packages generated during GMP release/stability testing of drug substance and drug product at the contract manufacturing sites.
- Assist in investigations and formulate a plan to identify/confirm root cause for anomalous results.
- Write and/or review method validation and transfer protocols and reports.
- Write and/or review protocols and reports related to stability studies as well as prepare tables summarizing results from stability studies.
- Establish a system for tracking and trending release and stability data for batch analysis and shelf life establishment.
- Initiate change control for internal specifications and regulatory documents.
- Evaluate and perform risk assessment for change control documents provided by the contract manufacturing sites
- Establish a reference standard program for drug substance, impurities and degradants.
Experience and Skills:
- B.S. or M.S in Analytical Chemistry or related scientific disciplines with 5+ years of experience in analytical development with minimum of 3+ years of experience in quality control.
- Prior experience in interacting with contract labs and manufacturing sites is a plus.
- Hands-on experience with validation and transfer in support of pharmaceutical manufacturing.
- Proficiency in performing root cause analysis for investigation.
- Experience with iStability software is a plus
- Detail oriented with exceptional organizational skills.
- Excellent written and verbal communication skills.