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.

• 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

• 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%

• 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…