Associate Director – Engineering

Role Overview

• Create, lead and execute technical transfers to and commercial supply from External Partner(s).
• Collaborate across multiple technical functions to ensure the success technical transfer and commercial manufacture with the External Partner(s).
• Provide a single point of technical contact to assigned External Partners.
• 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).
• Provides technical guidance to the External Partner, assess viability of technology in proposed process configurations, verify adherence to required standards.
• 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.
• Leads team for identification and assessment of partner risks and develops mitigation plans.
• 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.

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
• 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.

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