Manufacturing Science and Technology Senior Scientist
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Transatlantic Cost of Living & Purchasing Power Benchmark
Position Overview & Specifications
The MSAT Senior Scientist provides a critical technical role for the Commercial Manufacturing & Supply Chain, focused on Cell and Gene therapies, reporting to the MSAT Senior Manager/Principal Scientist. Under supervision, the Senior Scientist is responsible for product commercialization activities (PPQ, PLI readiness etc.), post-approval process monitoring (CPV, OOS, OOT and Deviation handling), and change management.
Develops timelines, communicated with key stakeholders, to ensure MSAT activities are prioritized and executed to meet the requirements of the program. Contributes to cross-functional teams (VCGT, External Manufacturing, Supply Chain, and Quality functions) to ensure that process validation, technology transfer, deviation management, process monitoring and post-approval change management are managed within agreed processed and are on target.- Resolves issues independently, where possible, and escalates other risks appropriately.
- Partner effectively and manage relationships with external CDMOs and key suppliers to meet manufacturing and program goals.
- Through the development of process data driven reports, support compliance and efficiency related projects working towards the goal of continuous improvement to increase value and efficiency.
- Provide support and applicable manufacturing process related content for CMC regulatory submissions and assist with technical CMC regulatory/Agency questions.
- Bachelor's Degree in science or related discipline is required, or equivalent experience.
- Experience with process development and technical support of commercial biological products and cGMP manufacturing. Experience with Cell and Gene therapies preferred.
- Knowledge of US and EU cGMP regulations/guidance.
- Experience with technology transfer, process validation and process monitoring.
- Direct experience working with contract manufacturing organizations (CDMO) and/or technical service partners.
- Technical experience supporting manufacturing quality compliance including deviations, change controls and CAPAs.
Strong background in Cell and Gene Therapy pharmaceutical manufacturing processes and technologies.- Knowledge of current Good Manufacturing Practices (cGMP) and regulatory requirements related to pharmaceutical manufacturing.
- Experience with process development and scale-up of pharmaceutical manufacturing processes, including process optimization, troubleshooting, and validation.
- Experience with statistical analysis (including JMP) for process optimization and validation.
- Excellent communication skills, both verbal and written, with the ability to communicate complex technical information to a range of stakeholders.
- Strong problem-solving and critical thinking skills, with the ability to analyze data and make sound technical recommendations.
- Strong leadership skills to contribute to, and provide technical guidance to, cross-functional teams.
- Travel required: 25% primarily in the EU and some (limited) US travel.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For four years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the company, please visit
Candidate Selection & Onboarding Process
Application & Resume Screening
Submit your tailored CV/Resume directly to the talent acquisition portal.
Technical & Competency Interviews
Virtual interviews with the hiring manager and multidisciplinary team.
Formal Offer & Benefits Negotiation
Written agreement outlining compensation, equity, retirement vesting, and relocation allowances.
Onboarding & Corporate Integration
Equipment provisioning, team orientation, and commencement of duties.
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Manufacturing Science and Technology Senior Scientist • Vertex Pharmaceuticals
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