Analytical Sciences & Technology Associate Director

Job Description

The Associate Director of Potency, 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 Potency subject method expert (SME) 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 potency assay development, validation, transfer, and lifecycle management for late-stage and commercial applications. Key responsibilities include executing analytical strategy per regulatory guidelines, providing strategic oversight of drug substance and drug product analytical methods, reference standards, structural-function 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 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:

• Accountable for the strategy and execution of potency methods activities (development, gap analysis, validation, transfer, continuous improvement, reference standard strategy) to support late-stage programs and manage the analytical lifecycle of commercial programs.
• Responsible for the strategic development of potency method transfer and validation. Design validation studies following ICH and FDA guidelines, review and approve plans, protocols, deviations, investigations, data, and summary 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.
• Represent AS&T on CMC teams to influence product development and build stakeholder relationships. Collaborate on technical, compliance, and regulatory strategies for the maintenance of Vertex products with suppliers.
• 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.
• Review potency regulatory guidance documents for the testing of biological products and advise on actions that could adversely affect the program or represent opportunities to be pursued.
• Be accountable for the success of AS&T activities, project planning, prioritization, managing timelines, and ensuring the quality of deliverables to meet program commitments

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)
• 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)
• Demonstrated proficiency with 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
• 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:

• 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.

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