QC Senior Scientist II

Overview

Pharmaron is seeking a QC Senior Scientist II to play a critical role in supporting API manufacturing and technology transfer programs within a GMP-regulated environment. The QC Senior Scientist II will serve as a technical leader within QC, working cross-functionally with Analytical Development, Manufacturing, and Quality to ensure the successful execution of complex programs.

• Participate in method transfer activities, including writing protocols, executing experiments and writing reports.
• Provide technical leadership and mentorship to QC team members
• Review and approve analytical data, protocols, and reports to ensure scientific rigor and compliance
• Drive root cause investigations and deviation resolutions, identifying practical and scalable solutions
• Serve as a subject matter expert (SME) for analytical instrumentation and QC processes
• Collaborate cross-functionally with Process Chemistry, Analytical Development, and QA
• Support regulatory inspections and audits, ensuring inspection readiness
• Contribute to continuous improvement initiatives to enhance efficiency and compliance
• Prepare and present data summaries (written and oral) as necessary. Present to cross functional teams and effectively communicate critical QC/analytical issues and solutions.
• Lead on the implementation and adoption of key internal business practices and applicable external regulations (e.g. GxP), and adhere to all policies governing their business activities.
• Perform other related assignments and duties, as required and assigned.

• D. in Chemistry (or related field) with 5+ years of experience, OR
• MS with 8+ years, OR BS with 10+ years in pharmaceutical/CDMO environments
• Strong hands-on expertise with HPLC, GC, FTIR, and Mass Spectrometry
• Proven experience in method transfer, validation, and GMP testing
• Deep understanding of cGMP, FDA, EMA, and ICH guidelines
• Demonstrated ability to troubleshoot complex analytical challenges
• Experience mentoring or leading junior scientists is highly preferred
• Strong communication skills and ability to work in fast-paced manufacturing environments

Location:

Coventry, RI |

Work Schedule:

2nd shift (2:30 pm – 11:00 pm) | Salary Range: $110k – $130k

• 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