Director Model Validation Jobs in Frederick, MD (NOW HIRING)

Director, Manufacturing

Location: This position is currently remote. A future transition to an on-site location on the U.S. East-Coast/Mid-West is anticipated as the project progresses, with an expected timeline in 2027. This is a full-time role with a Monday-Friday schedule from 8:00 a.m. to 5:00 p.m.

What you will get:

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).

Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.

What will you do:

The Director, Manufacturing - US Growth Investment Projects is responsible for developing and executing the operational readiness strategy for an assigned U.S. growth investment project supporting bioconjugate drug substance manufacturing. This role serves 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.

Working closely with the End-to-End Program Lead, Global Engineering, Quality, MSAT, Manufacturing, Automation, EHS, HR, and Finance, the Director will 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

• Serve as the primary Operations representative for facility and process design reviews, ensuring manufacturing requirements are incorporated into equipment, automation, process flow, and facility decisions

• 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

What we are looking for:

• 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

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

• 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

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. 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.