Analytical Science and Technology Principal Scientist

Job Description

The Principal Scientist, Biologics, Cell, and Gene Therapy (BioCGT), plays a critical role within the Analytical Science & Technology team, reporting to the Vertex MS&T function. The successful candidate will act as the subject matter expert (SME) for flow cytometry and cell potency assays. They will lead the analytical method lifecycle management (ALCM) activities for late-stage and commercial applications and provide E2E analytical supports to commercial manufacturing and quality control of Cell and Gene therapy (CGT) products. The Principal Scientist role will collaborate closely with all departments within Vertex and with contract testing sites establishing solid partnerships to ensure compliance with cGMP and Quality Management systems across the global network to effectively deliver our medicines to patients.

 
Key Responsibilities:

• Lead ALCM projects including late stage and post-marketing approval analytical activities such as method validation and method transfer.
• Be accountable for the success of ALCM projects/activities and ensure on-time deliverables to meet program commitments.
• Be a key contributor to analytical method continuous improvement and lifecycle management.
• Provide analytical supports to the troubleshooting and the investigations during routine manufacturing and quality control operations.
• Be primary SME for analytical testing and method performance executed at CDMOs and contract testing labs, with a focus on flowcytometry methods and potency assays.
• Own ALCM related change controls, deviations, CAPAs and investigations, as needed.
• Represent ASAT in the collaborations with internal Vertex functions including Regulatory CMC, Analytical Development, Process Development, Commercial Manufacturing, Supply Chain, and Quality teams.
• Support regulatory submissions and responses to health agency inquiries in late stage or post-market approval lifecycle.

Knowledge and Skills:

• Demonstrated expertise in biological assay development, validation, transfer, and troubleshooting compliant with GMP operations of Bio-CGT potency methods, including in-vitro cell-based functional/potency methods, in late-stage or commercial environments with a good understanding of GMP operation (required)
• Hands-on experience and in-depth understanding of Flow Cytometry techniques, specifically using BD FACs and/or Miltenyi MACSQuant
• Exceptional writing skills for technical documents, regulatory submissions and responses, investigations, and change controls, with a proven ability to collaborate in a matrix environment (required)
• Advanced knowledge of ALCM regulatory requirements, USP, and ICH guidelines (ICH Q2(R2)).
• Experience in managing contract testing sites (CROs, CMOs) for biologics method development, characterization, technology transfer, and Quality Testing
• Experience of automated analytical instruments is a plus
• Proficient in critical evaluation and interpretation of data, visualization tools, and statistical analysis tools (e.g., JMP)
• Extensive knowledge of Benefit-Risk strategies, problem-solving/root cause analysis for analytical-related issues, and decision-making with the ability to influence colleagues.
• Strong time management and organizational skills with the ability to prioritize multiple projects in a fast-paced environment.

Education and Experience:

• B.S or M.S in Biology, Biochemistry, Cell & Molecular Biology and related fields with a minimum 12 years of experience in the pharmaceutical/biopharmaceutical industry.
• PhD in Biology, Biochemistry and related fields with a minimum of 8 years of industry experience.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

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 [email protected]