Associate Director (Engineering), Biologics External Manufacturing Technical Operations

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

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision benefits

401(k)

Job summary

Merck & Co. in West Point, PA currently seeks an Associate Director, Engineering in Biologics External Manufacturing Technology to lead compliance, supply, and continuous improvement across external partnerships for vaccines and biologics.

The role requires biologics manufacturing expertise, strong leadership, and collaboration with internal and external partners to assure on-time tech transfer, process validation, and risk mitigation while driving productivity and cost reductions.

Qualifications

• Requires a Bachelor's degree in Engineering, Science, or Business.
• Minimum 8 years post-bachelor's experience in vaccines/biologics manufacturing or related.
• Proven ability to lead tech transfers and complex programs.
• Strong problem-solving, leadership, and collaboration skills.
• Excellent communication, verbal and written.

Responsibilities

• Provide a single technical contact to external partners and manufacturing sites.
• Oversee complex partnership tech transfer delivery on time and within budget.
• Guide external partner tech transfer viability and process configurations.
• Ensure adherence to standards and deliverables are technically sound.
• Collaborate with procurement and quality to evaluate external partners.
• Position tech transfers for successful business outcomes; ensure readiness.
• Lead risk assessments and mitigation planning for partners.
• Develop and execute validation strategies for products.
• Provide process support to resolve production issues with partners.
• Coordinate cross-functional communication and change leadership.
• Manage investigations with interface to other sites.
• Plan resources across technical functions.
• Review change requests and deviations to minimize duplication.
• Drive continuous process verification and performance monitoring.
• Ensure inspection readiness with commercialization, quality and regulatory.

Skills

Coordinate partnerships

Adaptability

Automation systems

Biologics

Capital project management

Change management

Data analysis

Process alignment

Lean manufacturing

Matrix management

Regulatory compliance

Problem identification

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 primary location for this posting is:
USA - Pennsylvania - West Point

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:
$142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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