Mfg Operations Associate Director Biologics, Drug Substance

Job Description

General Summary:

The Associate Director Technical Services is accountable for the technical execution of biologics drug substance manufacturing at external manufacturing partners.

This role is responsible for ensuring processes are executed as intended and delivering reliable supply. The Associate Director serves as the technical leader for manufacturing execution driving performance standardization and rapid issue resolution across programs and CDMOs.

The Associate Director Technical Services role is a key member of Vertexs External Manufacturing Organization (ExM) providing support strategic insights and enterprise thinking to the Biopharmaceutical Sciences and Manufacturing Operations organization (BSMO).

The Associate Director Technical Services is accountable for the technical execution of biologics drug substance manufacturing at external manufacturing partners. This role is responsible for ensuring processes are executed as intended and delivering reliable supply. The Associate Director serves as the technical leader for manufacturing execution driving performance standardization and rapid issue resolution across programs and CDMOs.

Key Duties and Responsibilities:

• Provide technical leadership for drug substance manufacturing campaigns at external partners serving as the senior technical decision-maker during active operations to ensure consistent compliant on-time execution and strong campaign readiness
• Oversee triage resolution and documentation of execution-related deviations ensuring rapid containment to protect product quality and supply
• Lead cross-functional coordination across MSAT Quality and manufacturing teams escalating and framing complex issues as needed
• Own process operability and execution robustness at the manufacturing site including batch record clarity and usability
• Drive improvements in yield cycle time right-first-time performance and overall manufacturing reliability
• Lead campaign readiness including implementation of CAPAs and process updates
• Serve as the senior technical interface during manufacturing operations providing day-to-day guidance and driving communication responsiveness and accountability at the site level during campaigns
• Oversee real-time monitoring of batch and campaign performance identifying risks process drift or execution gaps and drive timely technical interventions as needed to maintain schedule adherence quality and supply reliability
• Escalate complex or non-routine issues requiring deeper process understanding to MSAT ensuring clear technical framing and efficient handoff
• Oversee implementation of approved process and operational changes ensuring effective execution and expected performance outcomes
• Build and strengthen Technical Services capability within biologics including defining ways of working and developing technical staff
• Drive a culture of accountability urgency and operational rigor

Knowledge and Skills:

• Deep understanding of biologics drug substance manufacturing processes and cGMP operations
• Strong experience with real-time manufacturing support including batch execution deviation management and troubleshooting
• Ability to identify and resolve technical issues quickly in a live manufacturing environment
• Working knowledge of batch records investigations change control and quality systems
• Proven ability to operate effectively in a matrixed environment coordinating across MSAT Quality and manufacturing teams
• Strong communication skills with the ability to drive clear decisions under time-sensitive conditions
• Demonstrated focus on execution accountability and operational rigor
• Strong technical background in aseptic manufacturing operations.
• Solid project management skills and experience managing complex projects.
• Strong verbal and written communication skills: ability to expresses oneself clearly and concisely by adjusting style language and/or terminology as appropriate for the audience.
• Strong leadership and an innate ability to collaborate and build relationships is critical.
• Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
• Flexibility to work shift hours required to cover critical process steps
• Ability to travel national and international up to 30%

Education and Experience:

• BS/BA degree in Biological Sciences Chemical Engineering Chemistry or related discipline; advanced degree preferred
• Requires 10 years of experience in biologics manufacturing MSAT or external manufacturing
• Demonstrated experience supporting or leading manufacturing execution at a site or external partner
• Experience with deviation management investigations and real-time technical troubleshooting in a cGMP environment
• Prior experience working with external manufacturing partners strongly preferred
• Previous leadership experience including leading technical teams or cross-functional initiatives preferred
• Requires progressive experience in a management/leadership role in the biotechnology/ pharmaceutical industry with a focus on external manufacturing and commercial operations
• Excellent communication and interpersonal skills with the ability to influence cross-functional stakeholders and present insights to all levels of senior stakeholders
• Demonstrated continuous improvement mindset driving efficiencies process improvements across diverse initiative

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