Director, Manufacturing

About the role

The Director, Manufacturing – US Growth Investment Projects is a full-time role based remotely. A future transition to an on-site location on the U.S. East-Coast/Mid-West is anticipated, with an expected timeline in 2027.

Responsibilities

• Develop and execute the operational readiness strategy for an assigned U.S. growth investment project supporting bioconjugate drug substance manufacturing.
• Serve as the primary Operations representative throughout facility design, construction, commissioning, qualification, validation, start-up, and operational handover, ensuring the new facility is GMP-compliant, inspection-ready, and capable of supporting clinical and commercial manufacturing from day one.
• Work closely with the End-to-End Program Lead, Global Engineering, Quality, MSAT, Manufacturing, Automation, EHS, HR, and Finance to ensure operational requirements are embedded throughout the project lifecycle while building the future manufacturing organization and operating model.
• Lead operational readiness activities for an assigned U.S. growth investment project, ensuring successful start-up and transition into routine GMP manufacturing operations.
• Develop and execute the operations readiness roadmap, including organizational design, workforce planning, training strategy, process readiness, validation support, and operational handover.
• Define the future manufacturing organization, including staffing plans, shift structures, organizational interfaces, governance models, and operational ownership.
• Partner with Engineering, Quality, MSAT, Automation, and EHS to ensure operational requirements are appropriately integrated throughout project execution.
• Establish processes and systems that ensure GMP compliance, operational excellence, inspection readiness, and long-term manufacturing reliability.
• Lead operational planning and readiness activities associated with technology transfers, customer onboarding, process implementation, and commercial launch activities.
• Identify, assess, and mitigate operational, technical, organizational, and project risks associated with staffing, training, equipment readiness, start-up execution, and manufacturing performance.
• Build, develop, and lead a high-performing manufacturing organization while fostering a culture of accountability, safety, quality, and continuous improvement.
• Provide operational readiness updates, risk assessments, mitigation strategies, and recommendations to project governance teams and senior leadership.

Requirements

• Master’s degree in engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, or a related discipline preferred; bachelor’s degree with significant relevant experience will also be considered.
• 12+ years of leadership experience within pharmaceutical, biotechnology, biologics, or bioconjugate manufacturing environments.
• Demonstrated experience leading manufacturing operations within a CDMO environment, including customer-facing interactions, technology transfers, operational planning, and support of multiple client programs.
• Significant experience supporting or leading bioconjugate drug substance manufacturing operations, including scale-up, validation, technology transfer, start-up, and commercial manufacturing.
• Proven experience supporting major capital projects, facility expansions, greenfield or brownfield investments, and manufacturing facility start-ups.
• Strong knowledge of GMP manufacturing operations, regulatory requirements, process validation, commissioning, qualification, operational readiness, and inspection preparedness.
• Demonstrated success leading large, cross-functional teams and influencing stakeholders across Operations, MSAT, Quality, Engineering, Automation, EHS, Supply Chain, HR, Finance, and Project Management.
• Strong understanding of customer requirements within a CDMO business model, including program execution, relationship management, and delivery against customer commitments.
• Strategic thinker with the ability to translate business objectives into scalable operational solutions.
• Excellent communication and executive presentation skills, with experience presenting to senior leaders, governance bodies, customers, and external stakeholders.
• Demonstrated capability to identify and mitigate operational, technical, compliance, and project execution risks.
• Knowledge of Lean Manufacturing, Six Sigma, automation systems, digital manufacturing platforms, and data integrity principles preferred.
• Ability to operate effectively in a fast-paced project environment with evolving priorities and multiple stakeholders.
• Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve.
• Willingness and ability to travel domestically and internationally up to approximately 25–30% of the time.

Qualifications

Master’s degree in engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, or a related discipline preferred; bachelor’s degree with significant relevant experience will also be considered.

Skills

• Leadership experience within pharmaceutical, biotechnology, biologics, or bioconjugate manufacturing environments.
• Experience leading manufacturing operations within a CDMO environment, including customer-facing interactions, technology transfers, operational planning, and support of multiple client programs.
• Experience supporting or leading bioconjugate drug substance manufacturing operations, including scale-up, validation, technology transfer, start-up, and commercial manufacturing.
• Experience supporting major capital projects, facility expansions, greenfield or brownfield investments, and manufacturing facility start-ups.
• Strong knowledge of GMP manufacturing operations, regulatory requirements, process validation, commissioning, qualification, operational readiness, and inspection preparedness.
• Success leading large, cross-functional teams and influencing stakeholders across Operations, MSAT, Quality, Engineering, Automation, EHS, Supply Chain, HR, Finance, and Project Management.
• Understanding of customer requirements within a CDMO business model, including program execution, relationship management, and delivery against customer commitments.
• Strategic thinking and ability to translate business objectives into scalable operational solutions.
• Communication and executive presentation skills, with experience presenting to senior leaders, governance bodies, customers, and external stakeholders.
• Capability to identify and mitigate operational, technical, compliance, and project execution risks.
• Knowledge of Lean Manufacturing, Six Sigma, automation systems, digital manufacturing platforms, and data integrity principles.
• Ability to operate effectively in a fast-paced project environment with evolving priorities and multiple stakeholders.
• Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve.
• Willingness and ability to travel domestically and internationally up to approximately 25–30% of the time.

Benefits

The full-time base annual salary for this position is expected to range between $198,900 to $232,050. In addition, below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus.
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).

Pay

The full-time base annual salary for this position is expected to range between $198,900 to $232,050.

Schedule

This is a full-time role with a Monday–Friday schedule from 8:00 a.m. to 5:00 p.m.

Contact Information

If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now. Reference: R77587