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Associate Director, Engineering – Biologics External Manufacturing Technical Operations
MSD. Provide a single point of technical contact to assigned External Partners, impacted Company Manufacturing Division sites, and Commercialization .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in technical transfer delivery and risk assessment while ensuring compliance with regulatory requirements. Proven ability to lead cross-functional teams and optimize manufacturing processes in collaboration with external partners.
Highest-signal resume keywords
Technical Transfer DeliveryDrug Substance ManufacturingLean Manufacturing ApplicationsCross-Functional Team LeadershipRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Technical OversightTechnology Viability AssessmentValidation Strategies DevelopmentProcess Performance MonitoringRisk Mitigation PlanningChange ManagementProduction Issue ResolutionMaster Batch Record ReviewComplex Investigations ManagementDrug Product Manufacturing
Soft Skills
LeadershipCollaborationAnalytical SkillsVerbal CommunicationWritten Communication
Industry Keywords
Biologics ManufacturingVaccine ProductionMatrix Organization StructuresInternational EnvironmentsManufacturing Operations
About the role
Key responsibilities & impact- Provide a single point of technical contact to assigned External Partners, impacted Company Manufacturing Division sites, and Commercialization
- Provide technical oversight, management, and planning support for complex partnership models
- Accountable for overall technology transfer delivery, on time and within budget
- Provide technical guidance to External Partners and assess technology viability, standards adherence, and technical soundness of deliverables
- Evaluate External Partners for inclusion in the Company Network and execute technical due diligence assessments
- Execute technical transfers and receiving-site readiness activities
- 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 optimizing processes and capacity
- Ensure communication and alignment across technical functions; guide and coach others in change leadership
- Support, coordinate, and manage complex investigations
- Determine resource plans across relevant technical functions
- Review External Partner process change requests, deviations, and Master Batch Record changes
- Drive continuous process verification and process performance monitoring programs
- Ensure External Partners are inspection ready for new product introductions and transfers
- Partner with Operations, Quality, and Regulatory to meet regulatory requirements efficiently
- Collaborate with External Partners to achieve business goals and establish a common culture
Requirements
What you’ll need- A Bachelor’s degree in Engineering, Science, or Business
- Minimum of 8 years post-bachelor’s degree experience in Drug Substance and/or Drug Product vaccines and/or biologics manufacturing, engineering, and/or technical support of operations
- 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, analytical, verbal communication, and written communication skills
- Preferred: An advanced degree in Engineering, Science, or Business
- Preferred: Experience leading cross-functional teams supporting manufacturing operations at internal sites or External Partners
- Preferred: Expertise and demonstrated accomplishments with Lean Manufacturing applications
- Preferred: Experience in complex international environments with matrix organization structures
- Preferred: Experience in Large Molecule unit operation design, startup, and/or operation
- Ability to travel approximately 25–30% within the designated US region
- Travel and flexibility in partner assignment location required; short-term travel assignments may be required
- US and Puerto Rico residents only
- No visa sponsorship
- Regular employee status
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days