Jobs at Vertex Pharmaceuticals

Leads commercial analytical activities for cell and gene therapy products, including analytical method validation, technology transfer, testing oversight, continuous improvement, and lifecycle management. Authors and reviews SOPs, protocols, and technical reports while ensuring compliance with GMP and ICH, USP, and EMA requirements. Partners with analytical and process development, manufacturing, supply chain, quality teams, CDMOs, and contract laboratories to support launch readiness and commercial product lifecycle management.

Supports bench-scale and high-throughput bioreactor process-development studies through mammalian and stem cell culture, aseptic processing, media preparation, sampling, harvesting, and cell counting. Operates, maintains, and troubleshoots bioreactors, perfusion systems, liquid-handling equipment, and cell counters. Documents studies, supports automated workflows, maintains data integrity, improves laboratory procedures, and collaborates with process development, engineering, and analytical teams.

Leads MSAT activities for cell therapy products, including process development, technology transfer, clinical and commercial manufacturing support, PPQ, investigations, change controls, regulatory submissions, continuous improvement, lifecycle management, and CDMO oversight. Establishes robust process performance, manages cross-functional deliverables and risks, supports commercial readiness and cost reduction, and contributes to process monitoring and operational excellence across manufacturing lines.

Develops and optimizes ligand-binding biomarker assays for clinical studies. Performs experiments to characterize biomarkers in human biofluids and tissues, conducts mock validation, prepares assay-readiness data packages, supports assay transfers to CROs, troubleshoots methods, and presents results to internal stakeholders. The role requires laboratory expertise in immunoassays, ELISA, molecular and cell biology, with preferred experience in genomic, cell-based, and flow cytometry assays.

Supports engineering needs for Vertex’s regulated GxP facilities, manufacturing systems, equipment, utilities, and infrastructure. Leads change management, design reviews, engineering assessments, lifecycle documentation, commissioning, qualification, validation, troubleshooting, and continuous improvement. Collaborates with manufacturing, R&D, quality, facilities, project engineering, and site leadership. Provides subject matter expertise for regulatory inspections and ensures compliance with cGMP, FDA requirements, and applicable engineering standards.

Oversee revenue accounting for order-to-cash activities, including product revenue, accounts receivable, gross-to-net accruals, collections, credit assessment, reconciliations, month-end close, and financial reporting. Partner with commercial, market access, trade, distribution, and external service-provider teams. Lead process improvements, automation, analytics, forecasting support, systems development, and policy enhancements while reviewing team work as needed.

Supervise media, buffer, and stock solution preparation for biopharmaceutical and cell therapy manufacturing. Lead scheduling, staffing, troubleshooting, quality, GMP compliance, documentation, investigations, and CAPAs. Coach and develop team members while partnering cross-functionally on scale-up, manufacturing readiness, automation, lean improvement, and process optimization. Ensure safe, reliable, and high-quality operations in a laboratory, pilot-scale, or manufacturing support environment.

Serve as a technical business partner delivering and supporting COTS and custom PPM solutions. Lead evaluation, selection, implementation, lifecycle planning, vendor management, and compliance activities. Drive process improvements, align technology to business strategy, manage delivery for large complex projects, and collaborate with compliance, audit, and QA teams. Support Agile delivery and oversee outsourced/managed services.

Supports site manufacturing scheduling for a biotechnology organization by maintaining an aligned production plan, coordinating schedulers and stakeholders, identifying conflicts and dependencies, communicating schedule changes, and overseeing RTMS scheduling processes. The role ensures data quality, timely system updates, issue escalation, and alignment with manufacturing priorities and governance in a cGMP-regulated environment.

Leads process development and engineering studies for cell therapy products, including process robustness, characterization, optimization, and manufacturing investigations. Designs experiments, analyzes data, manages complex troubleshooting, and documents results. Leads and trains a weekend shift team, coordinates coverage and resources, and collaborates cross-functionally to meet clinical development goals. Supports pluripotent stem cell culture, bioreactor operations, technical reports, regulatory filings, and issue mitigation. This is a full-time on-site weekend and holiday shift role.

Leads cell-based drug process development studies covering cell banking, hESC expansion, process optimization, robustness, characterization, and data analysis. Applies engineering, GMP, QbD, and DOE principles; evaluates bioprocess technologies; troubleshoots manufacturing issues; authors protocols and technical reports; supports technology transfers and regulatory filings; coordinates cross-functional execution; and mentors colleagues.

Leads enterprise third-party risk management operations and governance, translating strategic priorities into execution. Oversees risk assessments, supplier criticality, issue remediation, monitoring, governance forums, executive reporting, metrics, managed service providers, and scalability planning. Partners cross-functionally with sourcing, legal, compliance, security, finance, quality, and enterprise risk teams to improve processes, automation, stakeholder experience, and operational effectiveness. Manages team members and drives continuous improvement across the TPRM program.

Provides technical, strategic, and operational leadership for pharmaceutical process engineering and manufacturing activities. Leads technology transfers, process validations, statistical process control, continuous improvement, quality investigations, and CMC development. Represents Process Engineering on cross-functional teams, supports regulatory and compliance requirements, manages suppliers and multiple projects, and develops staff. The role requires strong GMP, QbD, data analysis, and pharmaceutical manufacturing expertise.

Leads QC technical services for commercial small-molecule programs, overseeing external laboratories conducting GMP release and stability testing. Manages quality events, performance metrics, compliance, audits, regulatory submissions, and continuous improvement while ensuring continuity of supply. Provides strategic oversight, cross-functional coordination, external laboratory relationship management, and team development. Requires substantial pharmaceutical or biopharmaceutical QC leadership experience, analytical chemistry expertise, and knowledge of regulatory requirements.

Conduct independent preclinical pharmacology research evaluating compounds in ex vivo and in vivo disease models. Design and analyze flow cytometry and cell-sorting experiments, perform animal handling, dosing, perfusion, fluid collection, tissue processing, and ELISA assays. Troubleshoot protocols, conduct statistical analyses, prepare study documents and reports, contribute to publications and patents, and present findings. Work primarily with rodent and large-animal samples while collaborating with cross-functional research teams.

Leads trade and distribution analytics supporting business performance, market access, contract operations, field accounts, and product launches. Responsibilities include quarterly business reviews, demand and inventory reporting, data engineering, analysis, visualization, vendor analytics, process improvement, dashboard development, launch coordination, and presentation of actionable insights. The role partners extensively across commercial, finance, compliance, legal, regulatory, supply chain, and technology teams.

Owns global logistics performance reporting, KPI dashboards, TMS master data governance, annual budgeting, freight accruals, and variance analysis. Partners with logistics, finance, procurement, data, and technology teams to improve data products, automate reporting, maintain data quality, and support digital transformation. Presents performance and financial insights to senior leadership, drives cross-functional alignment, and serves as the logistics end-user representative for analytics requirements.

Leads preparative chromatography method development, scale-up, and purification campaigns for pharmaceutical drug substances in R&D and cGMP environments. Establishes kilo-lab chromatography infrastructure, supports kilogram-scale synthesis, and develops peptide and oligonucleotide purification capabilities. The role owns GMP documentation, quality and safety compliance, cross-functional technical initiatives, and mentorship of scientific staff.

Leads Procure-to-Pay process and platform enablement across requisitioning, purchasing, receiving, invoicing, matching, supplier information management, controls, and operational payment handoffs. Owns the P2P roadmap, continuous improvement, release readiness, UAT, change management, supplier data quality, and cross-functional collaboration with Procurement, Finance, IT, Data, and Operations. Drives automation, AI adoption, compliance, user experience, and stable financial execution.

Leads technical services for Type 1 Diabetes cell therapy manufacturing operations. Oversees GMP manufacturing support, troubleshooting, deviations, investigations, process monitoring, readiness, process changes, and manufacturing performance. Partners with Manufacturing, Quality, Engineering, Supply Chain, Regulatory, and CMC teams while building and mentoring a technical services organization. Requires deep advanced therapy manufacturing expertise, strong cross-functional influence, and extensive people leadership.