Mfg Operations Associate Director - Biologics, Drug Substance

General Summary

The Associate Director, Technical Services is accountable for the technical execution of biologics drug substance manufacturing at external manufacturing partners, ensuring intended process execution and reliable supply. Serves as technical leader for manufacturing execution, driving performance, standardization, and rapid issue resolution across programs and CDMOs.

• Provide technical leadership during drug substance manufacturing campaigns; ensure consistent, compliant, on-time execution and campaign readiness.
• Oversee triage, resolution, and documentation of execution-related deviations; ensure rapid containment to protect quality and supply.
• Lead cross-functional coordination (MSAT, Quality, manufacturing); escalate and frame complex issues as needed.
• Own process operability and execution robustness (including batch record clarity/usability).
• Drive improvements in yield, cycle time, right-first-time performance, and manufacturing reliability.
• Lead campaign readiness (including CAPAs and process updates).
• Serve as senior technical interface during operations with day-to-day guidance and site-level accountability.
• Monitor batch/campaign performance in real time; identify risks/drift/gaps and drive timely technical interventions.
• Oversee implementation of approved process/operational changes.
• Build Technical Services capability and develop technical staff; define ways of working.
• Drive accountability, urgency, and operational rigor.

• Deep biologics drug substance manufacturing and cGMP operations knowledge.
• Real-time manufacturing support: batch execution, deviation management, troubleshooting.
• Working knowledge of batch records, investigations, change control, and quality systems.
• Strong matrix leadership and communication; able to make decisions under time-sensitive conditions.
• Strong aseptic manufacturing technical background; solid project management.
• BS/BA in biological sciences/chemical engineering/chemistry or related (advanced degree preferred).
• 10+ years in biologics manufacturing/MSAT/external manufacturing; experience supporting/leading site/external partner execution.
• Experience with deviation management/investigations/real-time troubleshooting in cGMP.
• Leadership experience preferred.
• Flexibility for shift coverage; travel up to 30%.

$160,000 - $240,000