Senior Scientist-Stability Manager, QC

About Pharmaron
Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK, and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.

Position:
Senior Scientist I, QC

Salary Range: $100,000-$130,000

Location:

Coventry, RI

The Senior Scientist, QC supports technology transfer and GMP manufacturing activities through analytical method transfer, verification, validation, sample testing, and stability study management in compliance with applicable guidelines. The role also solves moderate complexity analytical and quality control issues for assigned projects and initiatives.

• Participate in method transfer activities, including writing method transfer and method validation protocols, executing experiments and writing reports.
• Mentor junior QC scientists on daily work, provide technical and compliance guidance.
• Conduct method validation, method verification and sample testing.
• Review experimental data, notebooks, method, protocols, and reports.
• Manage stability studies, draft stability protocols and reports, coordinate and perform sample testing.
• Actively investigate laboratory deviations, OOS, OOT, and atypical results; write investigation reports.
• Prepare and present data summaries (written and oral) to cross‑functional teams and communicate critical QC/analytical issues and solutions.
• Work successfully in both a team/matrix and independent environment.
• Ensure high quality in QC work and accurately document all necessary information per cGMPs.
• Participate, support, and facilitate site audits as directed and required.
• SME for instrument and training.
• Maintain good laboratory practices and GMP in compliance with safety and environmental requirements.
• Write, revise, develop, and evaluate SOPs.
• Perform other related assignments and duties as required and assigned.

• MS with 8+ years of experience or BS with 10 years of experience in the pharmaceutical industry.
• Evidence of experience in successful application of analytical skill sets to resolve scientific problems related to method optimization and/or implementation.
• Experienced troubleshooter of technical problems.
• 3 years of experience (may include Ph.D. experience) with core analytical instrumentation such as HPLC, GC, FTIR, and Mass Spectrometry.
• Evidence of ability to effectively contribute to multidisciplinary scientific teams.
• Working knowledge of cGLP/cGMP and applicable FDA, EMA, and ICH guidance.
• Evidence of ability to effectively scientifically supervise staff.
• Expert application of core laboratory techniques and instrumentation to impact API, intermediates, and starting materials.

• 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&DD Insurance, Short‑ and Long‑Term Disability Insurance.
• 401(k) plan with generous employer match.
• Access to an Employee Assistance Program.

As an Equal Employment Opportunity and affirmative action employer, Pharmaron values diversity and inclusion in the workplace and fosters an environment where all individuals are empowered to succeed.