Associate Director (Engineering), Biologics External Manufacturing Technical Operations

Merck•Upper Gwynedd Township, PA

3d•$142,400 - $224,100•Onsite

About The Position

The Associate Director, Engineering within Biologics External Manufacturing Technology is accountable for excellence in compliance, supply, continuous improvement, and cost reduction in partnership with internal technical partners and External Partner leadership, supporting the Vaccines and Biologics businesses. The role collaborates with the Focus Factory Operations lead, modality-specific Technology Leads, Large Molecule External Quality Assurance, Procurement, and other partners. The Associate Director serves as the technical point of contact for assigned External Partners and supports complex partnership models, technical transfers, receiving-site readiness, validation strategies, manufacturing process support, and process performance monitoring. The role guides partner selection and technical due diligence, assesses and mitigates risks, supports investigations and change reviews, and helps ensure partners are inspection-ready and meet regulatory requirements efficiently. The position also fosters alignment and a shared culture with External Partners while driving business goals and successful technical outcomes. The primary location is West Point, Pennsylvania. Travel is required for partner assignments, primarily within a designated U.S. region; the posting lists travel requirements of 30% and 25%. Relocation is not offered. The role is a regular employee position on the first (day) shift.

Requirements

Bachelor’s degree in Engineering, Science, or Business.
At least 8 years of post-bachelor’s-degree experience in Drug Substance and/or Drug Product vaccines and/or biologics manufacturing, engineering, and/or technical operations support.
Expertise and demonstrated accomplishments leading technical transfers.
Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues.
Excellent leadership, collaboration, change management, interpersonal, and analytical skills.
Ability to work as a team player with dependable verbal and written communication and interpersonal skills.

Nice To Haves

Advanced degree in Engineering, Science, or Business.
Experience leading cross-functional teams supporting manufacturing operations at internal sites or External Partners.
Expertise and demonstrated accomplishments applying Lean Manufacturing to achieve year-on-year productivity improvements.
Ability to motivate a team around a common vision and deliver expected results.
Creative, innovative, and self-motivated approach; problem-solving skills; and a solid foundation in engineering fundamentals and process troubleshooting.
Experience in complex international environments with matrix organizational structures.
Experience in Large Molecule unit-operation design, startup, and/or operation.

Responsibilities

Serve as the single technical contact for assigned External Partners, impacted Company Manufacturing Division sites, and Commercialization.
Provide technical oversight, management, and planning support for complex partnership models.
Own overall tech transfer delivery for External Manufacturing, ensuring delivery on time and within budget, and work with Operations Unit leadership to ensure activity resourcing.
Provide technical guidance to External Partners, assess technology viability in proposed process configurations, verify adherence to required standards, and ensure technical soundness of deliverables.
Collaborate with Procurement, External Manufacturing Operations, External Quality, Regulatory, and others to evaluate External Partners for inclusion in the Company Network; conduct technical due diligence assessments.
Execute technical transfers and receiving-site readiness activities, positioning transfers for successful business outcomes.
Lead identification and assessment of partner risks and develop mitigation plans.
Develop and execute validation strategies for new and existing products.
Support External Partners in resolving production issues and provide guidance on process and capacity optimization.
Ensure targeted communications and alignment across technical functions; guide and coach others in change leadership.
Support, coordinate, and manage complex investigations, interfacing with other impacted manufacturing sites as appropriate.
Determine resource plans across relevant technical functions.
Technically review External Partner process change requests, deviations, and Master Batch Record changes, and minimize duplicated efforts between partner and Company systems.
Drive and support continuous process verification and process performance monitoring for products under responsibility.
Work with Commercialization, Quality, Regulatory, and External Partners to ensure inspection readiness for new product introductions and transfers.
Clarify regulatory requirements and work with Operations, Quality, and External Partners to develop efficient approaches to meeting them.
Collaborate with External Partners to achieve business goals and establish a mutually beneficial common culture.