Associate Director, Analytical Science & Technology (Biologics/Cell & Gene Therapies)

The Associate Director of Biologics, Cell, and Gene Therapy (BioCGT) holds a matrix leadership position within the Analytical Science & Technology team, reporting to the Vertex MS&T function. This key leadership role involves effective communication and execution of an end-to-end analytical strategy with regular interactions with senior management. The successful candidate will act as the Analytical Technical Lead (ATL) responsible for overseeing program(s) through the late-stage drug development lifecycle, Biologics Licensure Application (BLA), and Life Cycle management. This leadership role will provide expertise and comprehensive analytical oversight and involves leading and facilitating analytical assay development, validation, transfer, and lifecycle management for late-stage and commercial applications. In addition, this role will also lead implementation and management of Reference Standards program for Vertex BioCGT portfolio. Key responsibilities include executing analytical strategy per regulatory guidelines, providing strategic oversight of drug substance and drug product analytical methods, reference standards, structural studies, and supporting control strategy establishment. Additionally, the Associate Director will be accountable for authoring regulatory filings, defining strategies for follow-up measures, prior approval submissions, and responding to health authority queries.

The Associate Director will partner 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.

• Accountable for the strategy and execution of analytical activities (method gap analysis, validation, transfer, continuous improvement, remediation, reference standard strategy) to advance late-stage programs and manage the analytical lifecycle of commercial programs.

• Responsible for leading the analytical development and quality control strategies during late-stage and post-approval phases. This includes developing and designing method transfer and validation studies per ICH and FDA guidelines, and reviewing plans, protocols, deviations, investigations, data, and reports.

• Author and review regulatory documents during Biological License Applications (BLA), & Post Approval Submissions (PAS), and responses to Follow Up Measures (FUMs), Post Marketing Commitments (PMCs), and commercial readiness (including site inspection).

• Collaborate with internal and external stakeholders to develop effective strategies for analytical activities by providing technical leadership for commercial GMP manufacturing and testing, focusing on method troubleshooting, quality events, change controls, and data trending to enhance commercial supply efficiency.

• Act as the main point of contact for reference standards and critical reagent management for late stage development and commercial programs.

• Develop and manage analytical commercial capabilities and strategies to ensure robust and compliant analytical methods and testing for commercial requirements.

• Represent AS&T on cross-functional CMC teams to influence product development for commercialization while building strong relationships with key stakeholders.

• Provide analytical oversight for CDMO, CTO, and third-party testing to support commercial manufacturing (In-Process Controls and release).

• Own/Review/Approve commercial documents to support new and existing commercial products (methods, SOPs, technical protocols/reports, change controls, etc.), and their continual improvement/update to ensure compliance and technical content.

• Effectively collaborate with an integrated cross-functional team to define technical and regulatory strategies that enable process validation, commercial manufacturing, and post-approval maintenance of Vertex products at current and new suppliers.

• Evaluate regulatory guidance documents in areas relevant to the testing of biological products and advise on actions that could adversely affect the program or represent opportunities to be pursued.

• Analyze data and metrics related to analytical performance, identifying trends, patterns, and potential areas of concern, and develop strategies for continuous improvement.

• Generate hypotheses and creative solutions to pursue project goals, and quality events, set new experimental directions, and overcome obstacles.

• In-depth knowledge of commercial biological assay development, validation, transfer, and troubleshooting compliant with GMP operations, supporting product development and/or commercialization.

• Strong leadership skills with the ability to communicate clearly and effectively in a matrix environment.

• In-depth knowledge of common analytical techniques used in the biopharmaceutical industry, with special emphasis on separation methods such as LC, CE, iCIEF, or process-related impurity (plate-based, qPCR)/safety/compendial methods.

• Comprehensive knowledge of cGMPs, ICH guidelines, and CMC regulatory considerations in a commercial setting.

• Familiarity with 2-tiered biologics reference standard requirements, including qualification, implementation, method performance monitoring, and re-qualification

• Exceptional writing skills for technical documents, regulatory submissions and responses, investigations, change controls, and corrective/preventative actions (CAPA).

• Experience contributing to CMC strategy through participation on the project team with the proven ability to build open and collaborative relationships and work effectively as a multidisciplinary team member.

• Experience in critical evaluation and interpretation of data, visualization tools, and statistical analysis tools (e.g., JMP) and/or sufficient knowledge of statistical concepts.

• 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.

• Experience managing CTO/CDMO analytical testing is highly desirable.

• Demonstrates advanced judgment balancing technical feasibility, opportunity, and impact while showing initiative and ability to capitalize on scientific creativity and insights.

• PhD, Master's or Bachelor's in Biological Sciences, Chemistry, Chemical Engineering, Biochemistry, Cell & Molecular Biology, Genetics, or related discipline.

• Typically requires the following, or the equivalent combination of education and experience: PhD and 8+ years, or Master's and 12+ years, or Bachelor's and 15+ years of relevant work experience.

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.