Analytical Science and Technology Senior Scientist

Job Description

General Summary:

The Sr. Scientist, Biologics, Cell, and Gene Therapy (BioCGT) holds a matrix position within the Analytical Science & Technology (AS&T) team, reporting to the Vertex Manufacturer Science & Technology function. The successful candidate will act as the subject method expert (SME) responsible to support program(s) through the late-stage drug development lifecycle, Biologics Licensure application (BLA), and Life Cycle management. This role will provide expertise and comprehensive analytical supports to assay validation, transfer, and lifecycle management for late-stage and commercial applications. The Sr. Scientist 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 Duties and Responsibilities:

• Collaborate on analytical method lifecycle management (ALCM) projects including late stage and post-marketing approval analytical activities such as method validation and method transfer.
• Be accountable for the success of AS&T activities, project planning, prioritization, managing timelines, and ensuring the quality of deliverables to meet program commitments.
• Be a key contributor to analytical method continuous improvement and lifecycle management.
• Be primary SME for analytical testing and method performance executed at CDMOs and contract testing labs, with a focus on flowcytometry related methods and/or compendia assays.
• Represent AS&T 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.
• Own ALCM related change controls, deviations, CAPAs and investigations, as needed.
• Support the assay control and/or reference standard qualifications to the related assays.
• Provide analytical supports to the troubleshooting and the investigations during routine manufacturing and quality control operations as needed.

Knowledge and Skills:

• Demonstrated expertise in assay development, validation, transfer, and troubleshooting compliant with GMP operations of Bio-CGT methods in late-stage or commercial environments with a good understanding of GMP operation (required)
• Advanced knowledge of safety methods, both compendia and non-compendia is desirable
• 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 Bio-CGT method development, characterization, technology transfer, and Quality Testing
• Hands-on experience with flowcytometry assays for CGT products (desirable)
• Experience in critical evaluation and interpretation of data, visualization tools, and statistical analysis tools (e.g., JMP) and/or sufficient knowledge of statistical concepts (preferred)
• 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 of 6 years of experience in the pharmaceutical/biopharmaceutical industry.
• PhD in Biology, Biochemistry and related fields with a minimum of 2-5 years of industry experience.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: 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.

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