MSAT Principal Scientist, Biologics

Vertex Inc.•Boston, MA

4d•Hybrid

About The Position

The Principal 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, with a focus on manufacturing process support, lifecycle management, and technical execution for biologics. Based at the Boston Seaport site, this 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.

Requirements

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.
Broad 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).
Experience with technology transfer, process validation, and process performance monitoring.
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.

Nice To Haves

Advanced degree preferred.

Responsibilities

Provide MSAT support across biologics manufacturing processes, spanning development, technology transfer, validation, and commercial lifecycle management.
Plan, prioritize, and execute 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.
Author and 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.
Provide manufacturing process expertise to support regulatory submissions and respond to technical questions from global health authorities.
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.