Associate Director (Engineering), Biologics External Manufacturing Technical Operations

Merck & Co.; Elmora (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays, vacation, sick days

Job summary

Merck & Co., Inc. in Rahway, NJ seeks an Associate Director, Engineering for Biologics External Manufacturing Technology. You will drive compliance, supply, and continuous improvement with external partners, leading tech transfers and risk management across global sites.

Required: 8+ years in biologics manufacturing, advanced problem solving, and strong leadership. Travel ~30% to partner assignments; strong cross-functional collaboration is essential.

Qualifications

• Bachelor's degree in Engineering, Science, or Business.
• 8+ years post-bachelor's experience in biologics/drug substance or product manufacturing, engineering or operations.
• Expertise and accomplishments leading technical transfers.
• Advanced problem-solving and team leadership.
• Excellent leadership, collaboration, change management, and communication skills.

Responsibilities

• Provide a single technical contact to External Partners and sites; manage complex partnership models.
• Oversee tech transfer delivery (on-time, within budget) with resource planning.
• Guide External Partner process changes and ensure technical soundness.
• Collaborate with Procurement, QA, Regulatory to evaluate and select External Partners.
• Position tech transfers for successful business outcomes and site readiness.
• Lead risk assessment and mitigation for partner programs.
• Develop and execute validation strategies for new/existing products.
• Support issue resolution and capacity optimization across partners.

Skills

Leadership

Change management

Collaboration

Analytical skills

Interpersonal skills

Communication

Problem solving

Project management

Education

Bachelor's degree in Engineering, Science, or Business

Advanced degree (preferred)

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 {+ 11 more}

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

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 .

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

Search Firm Representatives Please Read Carefully-

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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

*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.