MSAT Senior Scientist, Biologics
Listed on 2026-06-13
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Engineering
Manufacturing Engineer, Process Engineer, Quality Engineering, Validation Engineer
General Summary
The Senior Scientist/Engineer, Manufacturing Science and Technology (MSAT) – Biologics & Cell Therapy is a key technical role within the Commercial Manufacturing and Technology Operations (CMTO) organization. This position supports late‑stage clinical and commercial programs across the Vertex Biopharmaceutical Sciences and Manufacturing Operations (BSMO) network, focusing on manufacturing process support, lifecycle management, and technical execution for biologics. Based at the Boston Seaport site, the role partners closely with cross‑functional internal teams and external manufacturing partners to ensure robust, compliant, and scalable manufacturing processes that enable reliable clinical and commercial supply to patients.
Key Responsibilities- Provide MSAT support across biologics manufacturing processes, spanning development, technology transfer, validation, and commercial lifecycle management.
- Support execution of MSAT deliverables by developing and managing timelines aligned with program milestones and supply requirements.
- Contribute as a technical team member on cross‑functional project teams, ensuring manufacturing readiness and alignment across development, manufacturing, quality, regulatory, and supply chain functions.
- Apply strong process understanding and data‑driven decision‑making to support manufacturing performance, troubleshoot process issues, and assess risks to supply.
- Review technical reports and process data summaries to support deviations, investigations, change controls, CAPAs, and continuous improvement initiatives.
- Support technology transfer activities between development, internal manufacturing sites, and external partners, ensuring effective knowledge transfer and process understanding.
- Serve as a technical interface with contract manufacturing organizations (CMOs) and external partners, supporting execution, issue resolution, and alignment to program objectives.
- Contribute to process validation, continued process verification (CPV), and ongoing process monitoring activities in support of commercial operations.
- Drive a culture of continuous improvement, supporting initiatives to enhance process robustness, efficiency, and compliance.
- Work on site a minimum of 3 days per week; approximately 10% travel is expected.
- Minimum of 8 years of relevant experience in the biopharmaceutical industry, or an equivalent combination of education and experience.
- Bachelor’s degree in science or engineering (e.g., chemical engineering, biochemical engineering, biology, biotechnology) or equivalent; advanced degree preferred.
- Experience supporting late‑stage and/or commercial biologics products in a cGMP manufacturing environment.
- Understanding of manufacturing process development, scale‑up, and lifecycle support for complex biological products.
- Working knowledge of cGMP regulations and guidance across major global health authorities (e.g., FDA, EMA).
- Direct experience working with contract manufacturing organizations (CMOs) and/or external technical service providers.
- Experience supporting manufacturing quality systems, including deviations, investigations, change controls, and CAPAs.
- Strong written and verbal communication skills, with the ability to convey complex technical concepts to cross‑functional stakeholders.
- Demonstrated ability to work independently, manage multiple priorities, and exercise sound scientific and technical judgment.
$120,800 - $181,200
The range is based on a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Total Rewards also include medical, dental, and vision benefits; paid time off;
student loan repayment programs; commuting subsidies; charitable donation matching; 401(k) and other benefits.
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status- Hybrid: work remotely up to two days per week; or
- On‑Site: work five days per week on‑site with ad hoc flexibility.
Vertex is a global biotechnology company that invests in scientific innovation.
Equal Employment OpportunityVertex is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E‑Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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