Associate Director, Engineering

Job Description

General Summary: 

Due to continued growth and investment, our company is hiring an Associate Director, Engineering within Biologics External Manufacturing Technology.  

The Associate Director will be the key technical leader interface between our company and External Partners for the Biologics External Manufacturing (ExM) organization.    

This individual will create, lead and execute technical transfers to and commercial supply from External Partner(s). The candidate will be based in the US on the west coast and report to the Director, Biologics External Manufacturing Technology.   

The ideal candidate will be someone who can navigate a complex network of drug substance nodes across biologics modalities and tech support models. The candidate needs to collaborate across multiple technical functions to ensure the success technical transfer and commercial manufacture with the External Partner(s). This individual will be capable of leading several high-impact, complex, cross-functional divisional teams and will provide significant leadership to the department. This role is critical to the organization’s ability to support new and in-line commercial product technology transfers to External Partnerships, and support of our in-line products, with sharp oversight and technical risk management, focus on the rapidly expanding biologics third party network.   

Position Profile: 

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. 

Job Details: 

The primary focus of the Associate Director is to provide technical and project leadership to Biologics External Manufacturing business for: 

• Provides a single point of technical contact to assigned External Partners, impacted Company Manufacturing Division sites, and Commercialization.   

• Provides technical oversight, management, and planning support for complex partnership models.  Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues 

• 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. 

• Provides 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.   

• Collaborates with Procurement, External Manufacturing Operations, External Quality, Regulatory and others to evaluate External Partner(s) for inclusion in the Company Network.  Executes technical due diligence assessments at External Partner(s). 

• Ensures tech transfers are positioned for successful business outcomes.   Executes technical transfers and receiving site readiness activities. 

• Leads team for identification and assessment of partner risks and develops mitigations plans.   

• Develops and executes validation strategies for new and existing products. 

• Provides manufacturing process support to External Partner(s) to resolve production issues and to provide guidance on process and capacity optimization.     

• Ensures targeted communications and alignment across technical functions.  Guides and coaches' others in change leadership.   

• Support/Coordinate/Manage complex investigations, with appropriate interface with other impacted manufacturing sites 

• Determines resource plans across all relevant technical functions.   

• Provides a technical review of External Partner process change requests, deviations, and Master Batch Record changes.  Minimizes duplication of efforts between External Partner and Company systems. 

• Drive and support Continuous process verification and process performance monitoring program for all products under his/her responsibility 

• In concert with Commercialization, Quality, and Regulatory, ensures that External Partner(s) are inspection ready for all new product introductions and transfers. 

• Understands the true regulatory requirements and partners with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements.   

• Collaborates with External Partners to achieve business goals and to establish a common culture that benefits both Our Company and EP. 

Education Requirements: 

• A Bachelor’s degree in Engineering or applicable Science is required.  An advanced degree in Engineering, Science, or Business is preferred. 

• 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 is required 

Skill Requirements: 

• Expertise and demonstrated accomplishments leading technical transfers is required 

• Experience in leading cross-functional teams in support of manufacturing operations at internal sites or External Partner(s) is preferred 

• Expertise and demonstrated accomplishments with Lean Manufacturing applications to ensure year on year productivity improvements is preferred 

• Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues is required 

• Excellent leadership, collaboration, change management, interpersonal, analytical skills, collaboration, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written) is required.   

• Ability to motivate a team around a common vision and deliver expected results is preferred. 

• Creative, innovative, thinks outside of the box, self-motivated, applies problem-solving skills, and solid base in engineering fundamentals and process troubleshooting is preferred 

• Experience in complex international environment with matrix organization structures is preferred 

• Experience in Large Molecule unit operation design, startup, and/or operation is preferred.  

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

Location:  Location US is flexible.  Position may be based in Northern California or our company's Sites in the US

Reporting Structure:  This role will report to the Director, Biologics External Manufacturing Technology 

Required Skills:

Preferred Skills:

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The salary range for this role is

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.

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

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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. 

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