QC Senior Scientist II

Pharmaron • Coventry, RI

23h • Onsite

About The Position

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) dedicated to helping pharmaceutical and biotech companies develop new therapies. With over 21,000 employees across 23 locations in the US, UK, and China, Pharmaron provides fully integrated, high-quality services from drug discovery through manufacturing. The company supports various therapeutic modalities, including small molecules, ADCs, biologics, and gene therapies, and works with more than 3,000 global customers. 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. This position will serve as a technical leader within the QC department, collaborating cross-functionally with Analytical Development, Manufacturing, and Quality teams to ensure the successful execution of complex programs.

Requirements

• 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
• Strong communication skills and ability to work in fast-paced manufacturing environments

Nice To Haves

• Experience mentoring or leading junior scientists is highly preferred

Responsibilities

• 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.

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
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees