Qualifications

• MS with 6-8+ years or BS with 8-10+ years of pharmaceutical industry experience.
• Proven expertise in stability program management.
• In-depth knowledge of GMP QC compliance standards.
• Experience with lab deviation investigations, including OOS and OOT.
• At least 3 years of hands-on experience with HPLC, GC, FTIR, and KF instrumentation.
• Ability to contribute to multi-disciplinary scientific teams.
• Demonstrated supervisory experience in a scientific setting.

Responsibilities

• Manage stability studies and draft related protocols and reports.
• Train and mentor junior QC scientists, offering technical and compliance support.
• Review and validate experimental data, protocols, and reports.
• Participate in investigations of laboratory deviations and write detailed reports.
• Contribute to project teams and complete assigned tasks.
• Work effectively both independently and in a team/matrix environment.
• Ensure adherence to cGMPs through high-quality documentation and QC work.
• Facilitate site audits as needed, maintaining good laboratory practices.

Benefits

• Medical, dental, and vision insurance with strong employer contributions.
• Employer-funded Health Reimbursement Account for additional health costs.
• Flexible spending accounts for healthcare and dependent care.
• 100% employer-paid life insurance and disability coverage.
• Generous 401k plan with employer match for retirement savings.
• Access to an Employee Assistance Program for wellness support.