MS&T Associate Director – Biologics

Job Description

General Summary

The Associate Director MSAT Biologics provides technical and strategic leadership to support the successful transfer scaleup 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 crossfunctionally 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 fillfinish.
• Strong working knowledge of cGMP requirements and regulatory expectations for biologics manufacturing.
• Proven ability to lead crossfunctional 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

• Bachelors 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 latestage 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 jobrelated factors permitted by law.
At Vertex our Total Rewards offerings also include inclusive marketleading 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 weeklong 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 onsite 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 to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons 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 EVerify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at