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Analytical Sciences & Technology Associate Director
| Company | Vertex Pharmaceuticals |
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| Location | Boston, MA, USA |
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| Salary | $152800 – $229200 |
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| Type | Full-Time |
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| Degrees | |
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| Experience Level | Senior, Expert or higher |
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Requirements
- 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
- 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.
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.
Preferred Qualifications
- 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)
