Analytical Development Senior Research Scientist, Clinical Manufacturing Investigations

Job Description

General Summary:

Vertex is seeking a highly skilled and motivated Analytical Development Senior Research Scientist to join our team. This role is critical in ensuring the success of clinical manufacturing processes for our cell therapy programs by leading technical investigations, resolving quality events, and driving continuous improvement in analytical development. The ideal candidate will possess a strong scientific background, excellent problem-solving skills, and the ability to collaborate effectively across cross-functional teams.

Key Duties and Responsibilities:

• Technical Support and Investigations:

  • Act as the primary point of contact for technical support related to clinical run investigations.

  • Troubleshoot technical issues, perform in-depth root cause analyses, and develop hypotheses to address challenges.

  • Design and execute hypothesis-driven test protocols to identify and resolve technical issues.

  • Prepare comprehensive technical reports summarizing findings, conclusions, and recommendations.

• Investigation Leadership:

  • Lead and facilitate investigation meetings with cross-functional teams, including manufacturing, quality control, quality assurance, and analytical development.

  • Collaborate with technical Subject Matter Experts (SMEs) to develop and implement effective investigation strategies.

  • Drive timely resolution of technical issues to ensure the expedited release of drug products.

• Cross-Functional Communication and CAPA Implementation:

  • Serve as a liaison between manufacturing, quality control, quality assurance, and analytical development teams to address and resolve quality events.

  • Develop and implement Corrective and Preventive Actions (CAPA) to mitigate risks and prevent recurrence of issues.

  • Ensure timely communication and alignment across all stakeholders to maintain compliance and operational efficiency.

• Data Management and Analysis:

  • Oversee the management and analysis of analytical product characterization and method development datasets from clinical runs.

  • Utilize electronic systems for sample and data management, ensuring accurate data trending and reporting.

• Flexibility and Commitment:

  • Provide support for critical projects, including occasional weekend or late-night work, to meet organizational deadlines and ensure project success.

Knowledge and Skills:

• Technical Expertise:

  • Proficiency in a wide range of analytical platforms used for product characterization and release assays, particularly in the cell and gene therapy space.

  • Strong working knowledge of manufacturing and quality systems to support quality events, analytical investigations, and the development of corrective and preventive actions.

  • Experience with electronic systems for sample and data management, as well as data trending and analysis.

• Skills and Competencies:

  • Exceptional problem-solving abilities with a methodical and analytical approach to technical challenges.

  • Strong cross-functional communication and collaboration skills to effectively engage with diverse teams.

  • Proficiency in good documentation practices to ensure compliance with regulatory and quality standards.

Education and Experience:

• Ph.D. (or equivalent degree) and 2-5 years of relevant post-doctoral employment experience, or

• Masters Degree (or equivalent degree) and 5+ years of relevant employment experience, or

• Bachelors Degree (or equivalent degree) and 7+ years of relevant employment experience

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com