Job SummaryProvides scientific, technical, and operational support to the Quality Control organization while coordinating all aspects of the site's stability program. Conducts cGMP pharmaceutical testing to ensure regulatory compliance and safety. Assists in method transfers, verifications, and qualifications activities.
Responsibilities- Develop and maintain stability protocols, reports, and other related documentation to support the stability program.
- Manage stability chambers, including qualification, monitoring, and capacity planning.
- Ensure timely pull points, testing, data review, and reporting for all stability studies.
- Trend stability data, identify OOT/OOS signals, and support investigation related to stability samples
- Author, review, and revise QC SOPs, test methods, and technical documentation
- Document and maintain risk assessment reports in accordance with quality standards
- Conduct or participate in Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, root cause analysis and implementing Corrective/Preventive Actions (CAPA).
- Author, review, and approve technical documents, SOPs, and reports, ensuring adherence to FDA/EMA and cGMP regulations.
- Develop, validate, and transfer analytical methods as needed, troubleshoot instrumentation such as HPLC, UPLC and GC.
- Train and mentor junior analysts, and interface with clients or regulatory authorities.
Skills required- Deep knowledge of GMP regulations and advanced laboratory techniques.
- Strong Knowledge of in Empower and OpenLab chromatography software.
- Strong understanding of stability program requirements (ICH Q1A-Q1E).
- Familiarity with GMP, data integrity principles, and regulatory expectations.
- Strong organizational skills and ability to manage multiple studies and timelines.
- Excellent documentation, communication, and cross-functional collaboration abilities.
- Knowledge of method validation or lifecycle management.
- Ability to analyze data trends and contribute to technical investigations.
- Familiarity with regulatory guidelines (ICH, FDA, EMA)
- Maintain audit-ready documentation and support internal and external inspections.
- Well-organized, capable of multi-tasking and working on complex problems with sound scientific judgement
- Excellent data analysis skills with attention to detail and interpretation of results
- Excellent written and oral communication skills
- Experience with computer software such as WORD, EXCEL and chromatographic workstation systems
Education and experience- BS in Chemistry, Biochemistry, Analytical Chemistry or related field
- Minimum of 8 years of experience in GMP-regulated QC laboratory, preferably in pharmaceuticals or biotech
Physical Requirements- Prolonged periods of sitting at a desk and working on a computer
- Potentially prolonged periods standing
- Must be able to lift up to 15 pounds at times
Compensation:The base salary for this role starts at $120,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits and a discretionary annual target bonus for full-time positions.
