Associate Director, Engineering

MSD • Stockton, CA

1d • $142,400 - $224,100 • Remote

About The Position

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.

Requirements

• A Bachelor’s degree in Engineering or applicable Science is required.
• 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
• Expertise and demonstrated accomplishments leading technical transfers 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.

Nice To Haves

• An advanced degree in Engineering, Science, or Business is preferred.
• 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
• 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.

Responsibilities

• 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Manager