Sr. Scientist, QC
Pharmaron
Summary
The Senior Scientist - QC will support technology transfer and GMP manufacturing activities through analytical method transfer, verification, validation and sample testing in compliance with all applicable guidelines. Will also solve moderate complexity analytical and quality control issues for assigned projects and/or initiatives.
Job description
Job Overview
The Senior Scientist - QC will support technology transfer and GMP manufacturing activities through analytical method transfer, verification, validation and sample testing 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 protocols, executing experiments and writing reports.
- Supervise QC scientist daily work, provide technical and compliance related guidance.
- Review experimental data, notebooks, method, protocols / reports.
- Actively participate in investigations, problem solving, and troubleshooting.
- Write investigation reports.
- Coordinating QC testing, notebook and data review.
- 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 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 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
- 6 years of 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
Requirements
- 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
- 6 years of 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
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Time Off
- Paid Sick Leave
- Company Holidays
- Health Savings Account
- Flexible Spending Accounts
- Life Insurance
- AD&D Insurance
- Short-Term Disability
- Long-Term Disability
- Employee Assistance Program
- Fertility Support
- Maternity Resources
- Professional Development
Company overview
Pharmaron is a premier global life sciences service provider founded in 2004, offering comprehensive research, development, and manufacturing services throughout the entire drug discovery and development process. As a leading Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO), Pharmaron provides integrated solutions across multiple therapeutic modalities including small molecules, biologics, and cell and gene therapy (CGT) products. The company's extensive service portfolio encompasses synthetic and medicinal chemistry, biology services, DMPK (drug metabolism and pharmacokinetics), pharmacology, toxicology, radiochemistry, CMC (chemistry, manufacturing, and controls), and clinical development services. With over 10,000 employees worldwide and facilities across China, the United States, and Europe, Pharmaron supports pharmaceutical and biotechnology companies in accelerating their R&D programs from early discovery through commercial manufacturing. The company is publicly listed on both the Shenzhen and Hong Kong stock exchanges and maintains a strong commitment to scientific excellence, regulatory compliance, and technological innovation in the life sciences sector.