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Associate Director, Engineering

Merck
2 hours ago
On-site
West Point, PA
Operations
Key Responsibilities
- Manage and mentor a team of process engineers specializing in bioprocess manufacturing for large molecules (vaccines and biologics).
- Drive operational excellence for right-first-time (RFT) batch execution on the manufacturing floor.
- Collaborate with cross-functional teams to ensure agile pipeline deliverables are met.
- Manage end-to-end timelines of clinical campaigns coming in and out of the pilot plant through preparation, execution, and close out.

Education Minimum Requirement
- Bachelorโ€™s degree or Masterโ€™s degree in Engineering or Biological Sciences with a minimum of 7 years of relevant experience within the Pharmaceutical or Biopharmaceutical industry.

Required Experience and Skills
- Ability to work in a fast-paced, dynamic environment.
- Demonstrated ability to mentor team members and influence cross-functional groups.
- Technical knowledge of fermentation and cell culture processes, including aseptic techniques, live virus handling, BSL2 practices, cleanroom protocols, and/or bioprocessing equipment.
- Technical knowledge in purification processes such as chromatography, tangential flow filtration (TFF), and/or dead-end filtration.
- Knowledge of considerations for transitioning from development to GMP and influencing necessary adaptations.
- Strong understanding of cGMP, quality systems, and safety protocols within operations.
- Hands-on bioprocess experience (labs or operations).
- Previous experience leading projects in process development or GMP environments.

Preferred Experience and Skills
- Excellent organizational and problem-solving abilities.
- Ability to work independently and collaboratively.
- Exceptional conflict management and negotiation skills.
- Strong communication skills and personnel development aptitude.
- Prior management experience or experience leading teams.
- Experience with SAP inventory management system and/or SAP QN.

Required Skills
- Adaptability; Biopharmaceutical industry; cell cultures; chemical engineering; data-driven decision making; fast-paced environments; Good Manufacturing Practices (GMP); mammalian cell culture; manufacturing/manufacturing processes; manufacturing quality control; operational excellence; process optimization; safety compliance/protocols; SAP inventory management; strategic thinking; tangential flow filtration (TFF); technical mentoring; technical writing.

Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Application deadline is stated on the posting.

Requisition ID: R393138