MS&T Associate Director - Biologics

Job Description

General Summary

The Associate Director, MSAT Biologics provides technical and strategic leadership to support the successful transfer, scale‑up, validation, and lifecycle management of biologics manufacturing processes. This role serves as a key technical interface between development, manufacturing, quality, and external partners, ensuring robust, compliant, and efficient clinical and commercial operations. The Associate Director is expected to lead complex technical initiatives, mentor MSAT team members, and drive continuous improvement across the biologics manufacturing network.

Key Duties and Responsibilities

* Provide MSAT leadership 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.

Knowledge and Skills

* 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.

Education and Experience

* Bachelor's degree in Chemical Engineering, Biochemistry, Biology, or a related scientific discipline (advanced degree preferred).

* Typically requires 10+ years of relevant experience in biologics manufacturing, MSAT, or process development, or an equivalent combination of education and experience.

* Experience supporting late‑stage or commercial biologics manufacturing is strongly preferred.

Pay Range

This position is eligible for a competitive base salary, annual bonus, and equity awards.

Disclosure Statement

The range provided is based on what we believe is 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job‑related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market‑leading benefits to meet our employees wherever they are in their career, financial, family, and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental, and vision benefits to generous paid time off (including a week‑long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k), and more.

Flex Designation

Hybrid Designated

Flex Eligibility Status

In this Hybrid designated role, you will work on‑site a minimum of three days per week with flexibility for remote work on remaining days, consistent with business needs.

Note:

The Flex status for this position is subject…