Associate Director (Engineering), Biologics External Manufacturing Technical Operations

MSD Malaysia; West Point (PA); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Paid holidays

Job summary

Merck is seeking an Associate Director of Engineering in Biologics External Manufacturing Technology to lead tech transfer activities with External Partners and internal teams. The role emphasizes compliance, supply, continuous improvement, and cost reduction across Vaccines and Biologics.

You will oversee complex partnerships, validate processes, and guide cross-functional teams to ensure on-time delivery and robust process performance in a global environment.

Qualifications

• Bachelor’s degree in Engineering, Science, or Business.
• 8+ years post-bachelor’s experience in Drug Substance/Product vaccines/biologics manufacturing or related operations.
• Proven track record leading technical transfers and complex partnerships.
• Strong problem-solving, leadership, collaboration, and communication skills.

Responsibilities

• Provide a single technical contact to External Partners and internal sites for tech transfer delivery.
• Oversee complex partnership models and ensure on-time, on-budget delivery.
• Guide technical viability assessments and ensure adherence to standards.
• Lead risk assessment and mitigation for partner collaborations.
• Develop validation strategies and support tech transfers and process verification.
• Coordinate cross-functional teams across Regulatory, Quality, and Procurement.

Skills

Coordinate skills

Leadership

Problem-solving

Communication

Cross-functional collaboration

Lean Manufacturing

Regulatory Compliance

Project management

Analytical thinking

Change management

Education

Bachelor's degree in Engineering, Science, or Business

Job description

Job Description We aspire to be the premier research-intensive biopharmaceutical company. At the forefront of research, we deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and be part of a company that uses the power of leading-edge science to save and improve lives around the world. The Associate Director, Engineering within Biologics External Manufacturing Technology is accountable for achieving excellence in Compliance, Supply, Continuous Improvement & Cost Reduction in partnership with our internal technical partners and External Partner (EP) leadership, supporting the Vaccines and Biologics businesses. This individual works in collaboration with the Focus Factory Operations lead, modality specific Technology Leads, Large Molecule External Quality Assurance, and Procurement. The Associate Director must have biologics manufacturing experience, with broad process sciences and analytics, strong leadership skills, business acumen, and interpersonal skills.

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).
• Ensure tech transfers are positioned for successful business outcomes.
• Execute technical transfers and receiving site readiness activities.
• Lead team for identification and assessment of partner risks and develop mitigation plans.
• Develop and execute validation strategies for new and existing products.
• Provide manufacturing process support to External Partner(s) to resolve 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/Manage complex investigations, with appropriate interface with other impacted manufacturing sites.
• Determine resource plans across all relevant technical functions.
• Provide a technical review of External Partner process change requests, deviations, and Master Batch Record changes.
• Minimize duplication of efforts between External Partner and Company systems.
• Drive and support Continuous process verification and process performance monitoring program for all products under responsibility.
• In concert with Commercialization, Quality, and Regulatory, ensure that External Partner(s) are inspection ready for all new product introductions and transfers.
• Understand the true regulatory requirements and partner with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements.
• Collaborate with External Partners to achieve business goals and establish a common culture that benefits both our company and EP.

Qualifications Required

• A Bachelor’s degree in Engineering, Science, or Business.
• Minimum of 8 (eight) 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).

Preferred

• An advanced degree in Engineering, Science, or Business.
• Experience in leading cross-functional teams in support of manufacturing operations at internal sites or External Partner(s).
• Expertise and demonstrated accomplishments with Lean Manufacturing applications to ensure year on year productivity improvements.
• Ability to motivate a team around a common vision and deliver expected results.
• Creative, innovative, self-motivated, apply problem-solving skills, and solid base in engineering fundamentals and process troubleshooting.
• Experience in complex international environment with matrix organization structures.
• Experience in Large Molecule unit operation design, startup, and/or operation.

Travel Requirements

30% for partner assignments outside of primary location (primarily traveling within designated US region). Travel and flexibility in partner assignment location is required; may require short term travel assignments.

Required Skills

• Ability to Coordinate
• Ability to Coordinate
• Adaptability
• Automation Systems
• Biologics
• Capital Project Management
• Change Management
• Clinical Manufacturing
• Competency Development
• Contract Manufacturing
• Data Analysis
• Decision Making
• Drug Product Manufacturing
• External Manufacturing
• Interpersonal Relationships
• Lateral Thinking
• Lean Manufacturing
• Manufacturing Scale-Up
• Matrix Management
• Partner Relationship Management (PRM)
• Problem Identification
• Process Alignment
• Productivity Improvements
• Regulatory Compliance
• Regulatory Management

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.

The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

The salary range for this role is $142,400.00 - $224,100.00

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee).

The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 25%

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 09/4/2026

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.