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 manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.
Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.
Benefits:
As part of our commitment to your well-being, we offer a comprehensive benefits package:
- 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
