Senior Scientist I, QC

Position: Senior Scientist I, QC

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

Location: Coventry, RI

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.

We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

Job Overview:

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 all applicable guidelines. Will also solve moderate complexity analytical and quality control issues for assigned projects and/or initiatives.

Key Responsibilities

• 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 / reports.
• Manage stability studies, draft stability protocols and report, coordinate and perform sample testing.
• Actively participate in investigation of laboratory deviations, OOS, OOT, and atypical results. Write investigation reports.
• Prepare and present data summaries (written and oral) as necessary. Present to cross functional teams and effectively communicate critical QC/analytical issues and solutions.
• Ability to work successfully in both a team/matrix environment as well as independently.
• Ensure high quality in QC 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.
• 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.

What We're Looking For

• MS with 8+ years of experience or BS with 10 years of experience in 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, Mass Spectrometry.
• 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
  
• Expert application of core laboratory techniques and instrumentation to impact API, intermediates and starting materials

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manuf