Associate Director, Engineering

Merck; Geldern; Remote; EUR 126.000 - 199.000; Vollzeit

Zusammenfassung

Merck is seeking an Associate Director, Engineering within Biologics External Manufacturing Technology to lead technical transfers with external partners. The role focuses on governing complex, cross-functional programs spanning biologics tech transfer, process development, and validation, ensuring alignment with regulatory and quality expectations.

The ideal candidate has extensive experience in biologics manufacturing, strong leadership, and a track record of delivering high-impact projects

Qualifikationen

• Expertise and demonstrated accomplishments leading technical transfers.
• Experience leading cross-functional teams in manufacturing operations.
• Expertise with Lean Manufacturing to drive productivity improvements.
• Advanced problem-solving skills and leading teams to resolve complex issues.
• Excellent leadership, collaboration, and communication skills.

Aufgaben

• Provide technical leadership for biotech External Manufacturing technology transfers.
• Oversee tech transfer delivery, ensuring on-time, within budget.
• Collaborate with Procurement, QA, Regulatory and partners to evaluate external partners.
• Ensure site readiness and successful transfer of processes to external partners.
• Develop validation strategies for new and existing products.
• Support and optimize manufacturing processes at external partner sites.

Kenntnisse

Technical transfers

Cross-functional leadership

Lean manufacturing

Problem solving

Communication

Ausbildung

Bachelor’s degree in Engineering or Science

Tools

Jobbeschreibung

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

Adaptability, Automation Systems, Capital Project Management, Change Management, Clinical Manufacturing, Data Analysis, Decision Making, Drug Product Manufacturing, Interpersonal Relationships, Lean Manufacturing, Manufacturing Scale-Up, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Technical Transfer

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. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

No

Travel Requirements

50%

Flexible Work Arrangements

Remote

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a