Senior Scientist-Stability Manager, QC

Pharmaron • Coventry, RI

1d • $100,000 - $140,000 • Onsite

About The Position

The Senior Scientist-Stability Manager, QC will support GMP manufacturing activities through analytical sample testing, data review and stability management in compliance with all applicable guidelines.

Requirements

• MS with 6-8+ years of experience or BS with 8-10+ years of experience in pharmaceutical industry.
• Experienced in stability program management
• Expert in GMP QC compliance
• Experienced investigation of lab deviations, OOS, OOT and troubleshooting QC problems
• 3 years of experience with core analytical instrumentation such as HPLC, GC, FTIR, KF
• Evidence of ability to effectively contribute to multi-disciplinary scientific teams
• Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance
• Evidence of ability to effectively scientifically supervise staff

Responsibilities

• Manage stability studies, draft stability protocols and report, coordinate and perform sample testing.
• Train and mentor junior QC scientist, provide technical and compliance guidance.
• Review experimental data, notebooks, method, protocols / reports.
• Actively participate in investigation of laboratory deviations, OOS, OOT, and atypical results. Write investigation reports.
• Actively participate in project teams and perform assigned tasks.
• Ability to work successfully in both a team/matrix environment as well as independently.
• Ensure high quality in QC and analytical work, and accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
• Participate, support and facilitate site audits as directed and required.
• Maintain good laboratory practices and in compliance with safety and environmental requirements.
• Write, revise, develop, and evaluate SOPs.
• Perform other related assignments and duties, as required and assigned.

Benefits

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior