Associate Director; Engineering), Biologics External Manufacturing Technical Operations

Responsibilities:

• Serve as single technical point of contact for External Partners, impacted Manufacturing sites, and Commercialization.
• Provide technical oversight, management, and planning for complex partnership models.
• Lead tech transfer delivery (on-time, within budget); ensure resourcing with Operations leadership.
• Guide External Partners: assess technology viability/configurations, verify standards adherence, ensure technically sound deliverables.
• Coordinate external partner evaluation and technical due diligence with Procurement, External Manufacturing Operations, External Quality, Regulatory, and others.
• Execute tech transfers and receiving site readiness activities for successful business outcomes.
• Lead partner risk identification/assessment and mitigation planning.
• Develop and execute validation strategies; provide manufacturing process support to resolve issues and optimize process/capacity.
• Drive alignment/communications across technical functions; coach change leadership.
• Support/coordinate complex investigations across manufacturing sites.
• Review partner process changes, deviations, and Master Batch Record changes; minimize duplication between partner and company systems.
• Drive continuous process verification and performance monitoring; ensure inspection readiness for new introductions/transfers.
• Collaborate to meet regulatory requirements efficiently and build a shared partner culture.

• Bachelor’s degree in Engineering, Science, or Business.
• 8+ years post-bachelor’s in vaccines/biologics Drug Substance and/or Drug Product manufacturing, engineering, and/or technical ops support.
• Demonstrated expertise leading technical transfers.
• Advanced problem-solving; experience leading teams for complex business/technical issues.
• Strong leadership, collaboration, change management, interpersonal, analytical, and written/verbal communication skills.

• Advanced degree.
• Cross-functional leadership experience (internal sites or External Partners).
• Lean Manufacturing experience for productivity improvements.
• Experience in complex international matrix environments;
  Large Molecule unit operation design/startup/operation.

Travel: ~30% partner assignments (primarily within US region).

Salary/bonus/benefits:
Annual bonus and long-term incentive (if applicable); comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, sick/compassionate days).