Director, Manufacturing

This is a fully remote position, open to applicants in Maryland.

📋 Description

• The Director of Manufacturing – U.S. Growth Investment Projects is tasked with formulating and implementing the operational readiness strategy for designated U.S. growth investment initiatives focused on bioconjugate drug substance manufacturing.

• This position acts as the primary Operations representative during facility design, construction, commissioning, qualification, validation, start-up, and operational handover, ensuring that the new facility meets GMP compliance requirements, is inspection-ready, and is fully equipped to support clinical and commercial manufacturing from the outset.

• Collaborating closely with the End-to-End Program Lead, Global Engineering, Quality, MSAT, Manufacturing, Automation, EHS, HR, and Finance, the Director will embed operational requirements throughout the project lifecycle while shaping the future manufacturing organization and operational model.

• Lead operational readiness initiatives for an assigned U.S. growth investment project, guaranteeing a successful start-up and a seamless transition into standard GMP manufacturing operations.

• Create and implement the operations readiness roadmap, which encompasses organizational design, workforce planning, training strategy, process readiness, validation support, and operational handover.

• Define the future manufacturing organization, comprising staffing plans, shift structures, organizational interfaces, governance models, and operational ownership.

• Act as the primary Operations representative during facility and process design reviews, ensuring that manufacturing requirements are incorporated into equipment, automation, process flow, and facility decisions.

• Collaborate with Engineering, Quality, MSAT, Automation, and EHS to ensure that operational requirements are effectively integrated throughout project execution.

• Establish processes and systems that guarantee GMP compliance, operational excellence, inspection readiness, and long-term manufacturing reliability.

• Lead operational planning and readiness activities related to technology transfers, customer onboarding, process implementation, and commercial launch efforts.

• Identify, evaluate, 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 nurturing a culture of accountability, safety, quality, and continuous improvement.

• Provide updates on operational readiness, conduct risk assessments, devise mitigation strategies, and offer recommendations to project governance teams and senior leadership.

⛳️ Requirements

• A Master’s degree in engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, or a related field is preferred; a bachelor’s degree with extensive relevant experience will also be considered.

• Over 12 years of leadership experience within pharmaceutical, biotechnology, biologics, or bioconjugate manufacturing settings.

• Proven experience in leading manufacturing operations within a CDMO environment, including customer interactions, technology transfers, operational planning, and support for multiple client programs.

• Extensive experience in supporting or leading bioconjugate drug substance manufacturing operations, including scale-up, validation, technology transfer, start-up, and commercial manufacturing.

• Demonstrated success in supporting significant capital projects, facility expansions, greenfield or brownfield investments, and the start-up of manufacturing facilities.

• In-depth knowledge of GMP manufacturing operations, regulatory requirements, process validation, commissioning, qualification, operational readiness, and inspection preparedness.

• Proven ability to lead large, cross-functional teams and influence stakeholders across Operations, MSAT, Quality, Engineering, Automation, EHS, Supply Chain, HR, Finance, and Project Management.

• Experience in building manufacturing organizations, cultivating talent, and preparing teams for successful operational launch and long-term site performance.

• Strong understanding of customer needs within a CDMO business model, including program execution, relationship management, and meeting customer commitments.

• A strategic thinker capable of translating business objectives into scalable operational solutions.

• Exceptional communication and executive presentation skills, with experience delivering presentations to senior leaders, governance bodies, customers, and external stakeholders.

• Proven ability 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 is preferred.

• Capability to operate effectively in a fast-paced project environment with shifting priorities and multiple stakeholders.

• Willingness and ability to relocate to an East Coast or Midwest U.S. site location as project needs evolve.

• Willingness and capability to travel domestically and internationally up to approximately 25–30% of the time.

🏝️ Benefits

• Performance-related bonus.

• Medical, dental, and vision insurance.

• 401(k) matching plan.

• Life insurance, along with short-term and long-term disability insurance.

• Employee assistance programs.

• Paid time off (PTO).