Operations Director Jobs

About The Position

Requirements

• Bachelor’s degree in Engineering, Science, or Business.
• At least 8 years of post-bachelor’s 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, and analytical skills.
• Ability to work as a team player and demonstrate dependable interpersonal and verbal and written communication skills.

Nice To Haves

• Advanced degree in Engineering, Science, or Business.
• Experience leading cross-functional teams supporting manufacturing operations at internal sites or External Partners.
• Expertise and demonstrated accomplishments applying Lean Manufacturing to achieve year-over-year productivity improvements.
• Ability to motivate a team around a common vision and deliver expected results.
• Creative, innovative, and self-motivated approach, with problem-solving skills and a solid foundation in engineering fundamentals and process troubleshooting.
• Experience in complex international environments with matrix organization structures.
• Experience in Large Molecule unit-operation design, startup, and/or operation.

Responsibilities

• Serve as the single technical contact for assigned External Partners, impacted Company Manufacturing Division sites, and Commercialization.
• Provide technical oversight, management, and planning support for complex partnership models.
• Account for overall technology-transfer delivery to External Manufacturing, on time and within budget, working with Operations Unit leadership to ensure resources are available.
• Provide technical guidance to External Partners, assess technology viability in proposed process configurations, verify standards are met, and ensure deliverables are technically sound.
• Collaborate with Procurement, External Manufacturing Operations, External Quality, Regulatory, and other groups to evaluate External Partners for inclusion in the Company Network, including conducting technical due diligence.
• Ensure technology transfers support successful business outcomes, and execute transfers and receiving-site readiness activities.
• Lead identification and assessment of partner risks and develop mitigation plans.
• Develop and execute validation strategies for new and existing products.
• Support External Partner manufacturing and resolve production issues, providing guidance on process and capacity optimization.
• Ensure targeted communications and alignment across technical functions, and guide and coach others in change leadership.
• Support, coordinate, or manage complex investigations, interfacing with other impacted manufacturing sites as appropriate.
• Determine resource plans across relevant technical functions.
• Technically review External Partner process change requests, deviations, and Master Batch Record changes, minimizing duplication between External Partner and Company systems.
• Drive and support continuous process verification and process performance monitoring for products under responsibility.
• Work with Commercialization, Quality, and Regulatory to ensure External Partners are inspection-ready for new product introductions and transfers.
• Understand regulatory requirements and partner with Operations, Quality, and External Partners to develop efficient ways to meet them.
• Collaborate with External Partners to achieve business goals and establish a mutually beneficial common culture.

Benefits

• Medical, dental, and vision healthcare benefits.
• Other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.