Biologics External Manufacturing Lead

Merck & Co.; West Point (PA); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co. is seeking an Associate Director of Engineering in Biologics External Manufacturing Technology to lead tech transfer, compliance, and continuous improvement across partner sites for vaccines and biologics.

The role requires deep biologics manufacturing experience, strong leadership, and cross-functional collaboration with global external partners. The candidate will manage technical transfers, risk mitigation, and validation strategies, ensuring on-time delivery within budget while

Qualifications

• Bachelor's degree in Engineering, Science, or Business.
• 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 skills, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written).

Responsibilities

• 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 to External Manufacturing for overall tech transfer delivery (on-time, within budget), working closely with the Operations Unit leadership to assure resourcing for each activity.
• Provide technical guidance to the External Partner, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
• Collaborate with Procurement, External Manufacturing Operations, External Quality, Regulatory, and others to evaluate External Partner(s) for inclusion in the Company Network. Execute technical due diligence assessments at External Partner(s).

Skills

Coordinate

Adaptability

Lean Manufacturing

Change Management

Problem Solving

Interpersonal Skills

Leadership

Regulatory Compliance

Education

Bachelor's degree in Engineering, Science, or Business

Job description

Merck & Co. is seeking an Associate Director of Engineering in Biologics External Manufacturing Technology to lead tech transfer, compliance, and continuous improvement across partner sites for vaccines and biologics.

The role requires deep biologics manufacturing experience, strong leadership, and cross-functional collaboration with global external partners. The candidate will manage technical transfers, risk mitigation, and validation strategies, ensuring on-time delivery within budget while