Analytical Development Senior Research Scientist, Clinical Manufacturing Investigations
Vertex Pharmaceuticals
5 hours ago
On-site
Boston, MA
Operations
Key Duties and Responsibilities
- Act as the primary point of contact for technical support related to clinical run investigations.
- Troubleshoot technical issues, perform root cause analyses, and develop hypotheses.
- Design and execute hypothesis-driven test protocols.
- Prepare technical reports with findings, conclusions, and recommendations.
- Lead and facilitate investigation meetings with cross-functional teams (manufacturing, quality control, quality assurance, analytical development).
- Collaborate with technical SMEs to develop and implement investigation strategies.
- Drive timely resolution of technical issues to support expedited drug product release.
- Serve as a liaison between manufacturing, quality control, quality assurance, and analytical development to address and resolve quality events.
- Develop and implement Corrective and Preventive Actions (CAPA) to mitigate risk and prevent recurrence.
- Oversee management and analysis of analytical product characterization and method development datasets from clinical runs.
- Utilize electronic systems for sample/data management and ensure accurate data trending and reporting.
- Support critical projects, including occasional weekend or late-night work.
Knowledge and Skills
- Proficiency in analytical platforms for product characterization and release assays, particularly for cell and gene therapy.
- Working knowledge of manufacturing and quality systems for quality events, analytical investigations, and CAPA development.
- Experience with electronic systems for sample/data management and data trending/analysis.
- Exceptional methodical, analytical problem-solving.
- Strong cross-functional communication and collaboration.
- Proficiency in good documentation practices for regulatory/quality compliance.
Education and Experience
- Ph.D. (or equivalent) with 2–5 years relevant post-doctoral experience, or
- Master’s (or equivalent) with 5+ years relevant experience, or
- Bachelor’s (or equivalent) with 7+ years relevant experience.
- Act as the primary point of contact for technical support related to clinical run investigations.
- Troubleshoot technical issues, perform root cause analyses, and develop hypotheses.
- Design and execute hypothesis-driven test protocols.
- Prepare technical reports with findings, conclusions, and recommendations.
- Lead and facilitate investigation meetings with cross-functional teams (manufacturing, quality control, quality assurance, analytical development).
- Collaborate with technical SMEs to develop and implement investigation strategies.
- Drive timely resolution of technical issues to support expedited drug product release.
- Serve as a liaison between manufacturing, quality control, quality assurance, and analytical development to address and resolve quality events.
- Develop and implement Corrective and Preventive Actions (CAPA) to mitigate risk and prevent recurrence.
- Oversee management and analysis of analytical product characterization and method development datasets from clinical runs.
- Utilize electronic systems for sample/data management and ensure accurate data trending and reporting.
- Support critical projects, including occasional weekend or late-night work.
Knowledge and Skills
- Proficiency in analytical platforms for product characterization and release assays, particularly for cell and gene therapy.
- Working knowledge of manufacturing and quality systems for quality events, analytical investigations, and CAPA development.
- Experience with electronic systems for sample/data management and data trending/analysis.
- Exceptional methodical, analytical problem-solving.
- Strong cross-functional communication and collaboration.
- Proficiency in good documentation practices for regulatory/quality compliance.
Education and Experience
- Ph.D. (or equivalent) with 2–5 years relevant post-doctoral experience, or
- Master’s (or equivalent) with 5+ years relevant experience, or
- Bachelor’s (or equivalent) with 7+ years relevant experience.