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
Deep knowledge of GMP regulations and advanced laboratory techniques
Proficient in Empower and OpenLab chromatography software
Strong understanding of ICH Q1A-Q1E stability program requirements
Excellent documentation and communication skills
Ability to analyze data trends and contribute to technical investigations
Responsibilities
Develop and maintain stability protocols and documentation
Manage stability chambers, including qualification and monitoring
Ensure timely testing and reporting for stability studies
Trend stability data and support investigation of out-of-specification samples
Author and review QC SOPs and technical documents
Conduct OOS and OOT investigations and implement corrective actions
Train and mentor junior analysts and interface with regulatory authorities
Benefits
Diverse health benefits package
Discretionary annual target bonus for full-time positions
Opportunities for professional development and training
Support for maintaining audit-ready documentation
Engagement with regulatory authorities in a dynamic environment
Full Job Description
Job Summary
Provides 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.
