MS&T Associate Director – Biologics

Associate Director, MSAT Biologics – Technical and Strategic Leader for biologic manufacturing processes.
Key Responsibilities

Lead MSAT for biologics drug substance and/or drug product processes across clinical and commercial manufacturing.
Lead and support technology transfer activities from process development into internal and external manufacturing sites.
Serve as a technical subject‑matter expert during process validation, continued process verification, and lifecycle management activities.
Partner cross‑functionally with Process Development, Manufacturing, Quality, Regulatory, Supply Chain, and external CMOs to ensure aligned execution.
Provide technical oversight and root‑cause analysis for deviations, investigations, and CAPAs impacting biologics processes.
Support regulatory submissions and health authority interactions by authoring and reviewing technical documentation.
Drive continuous improvement initiatives to enhance process robustness, yield, and operational performance.
Mentor and develop MSAT scientists and engineers, fostering a culture of scientific rigor, accountability, and collaboration.
Qualifications

Bachelor’s degree in Chemical Engineering, Biochemistry, Biology, or related scientific discipline (advanced degree preferred).
10+ years of relevant experience in biologics manufacturing, MSAT, or process development.
Deep understanding of biologics manufacturing processes, including cell culture, purification, formulation, and/or fill‑finish.
Strong working knowledge of cGMP requirements and regulatory expectations for biologics manufacturing.
Proven ability to lead cross‑functional teams and influence technical and business decisions without direct authority.
Experience supporting technology transfer, process validation, and commercial manufacturing operations.
Demonstrated strength in problem solving, data analysis, and technical writing.
Excellent verbal and written communication skills with the ability to convey complex technical concepts to diverse audiences.
Compensation and Benefits

Pay Range: $168,000 – $252,000. Eligible for annual bonus and equity awards. Additional benefits include medical, dental, vision, paid time off, educational assistance, and more.
Vertex is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to 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.

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