Developing and executing the operational readiness strategy for a U.S. growth investment project is the core of this Director, Operations role. The project supports small molecule drug substance manufacturing. This position serves as the primary Operations representative throughout the facility's design, construction, commissioning, qualification, validation, start-up, and operational handover, ensuring the facility is GMP-compliant, inspection-ready, and capable of supporting reliable clinical and commercial manufacturing from day one.
Responsibilities
Lead operational readiness activities for the assigned U.S. growth investment project, including operating model development, staffing plans, training strategy, and start-up preparation
Define the future manufacturing organization, including workforce planning, organizational structure, shift models, governance processes, and operational ownership
Serve as the primary Operations representative during facility and process design to ensure manufacturing requirements are incorporated into equipment, automation, process flow, and facility decisions
Partner with Engineering, MSAT, Quality, Automation, and EHS teams to ensure operational requirements are integrated throughout project execution
Ensure manufacturing readiness and GMP compliance through commissioning, qualification, validation, inspection preparedness, and operational excellence activities
Lead operational planning and readiness activities associated with technology transfer, process implementation, and product introduction for small molecule manufacturing programs
Identify, assess, and mitigate operational, technical, and project risks related to staffing, training, equipment readiness, operational performance, and start-up execution
Build and develop a high-performing operations organization while providing readiness updates, risk assessments, and strategic recommendations to senior leadership and project governance teams
Requirements
Bachelor’s degree in engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related discipline; advanced degree preferred
12+ years of leadership experience in pharmaceutical or API manufacturing, including Operations, Manufacturing, Technical Operations, or related functions
Experience with HPAPI, complex chemical synthesis, or chemical process manufacturing is preferred
Demonstrated experience supporting or leading small molecule drug substance manufacturing operations, preferably in API, HPAPI, or complex chemical manufacturing environments, including commercial manufacturing, technology transfer, validation, and operational readiness
Proven experience supporting major capital projects, facility expansions, greenfield or brownfield investments, manufacturing start-ups, or large-scale growth initiatives
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Strong knowledge of GMP manufacturing operations, regulatory expectations, process validation, commissioning, qualification, and inspection readiness, and process safety principles within API or chemical manufacturing
Experience in containment-intensive manufacturing environments (e.g., HPAPI containment, isolators, contained material handling) preferred
Experience leading cross-functional teams and influencing stakeholders across Engineering, Manufacturing, Quality, MSAT, Automation, EHS, HR, Finance, and Project Management functions
Demonstrated success building organizations, developing talent, and establishing sustainable operating models within complex manufacturing environments
Strong communication, strategic planning, problem-solving, and change management skills, with the ability to effectively engage senior leadership and project governance teams
Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve
Benefits
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)
Important Details
Work format: This position is currently remote, with a future transition to an on-site location on the U.S. East-Coast/Mid-West anticipated in 2027
Schedule: Monday–Friday from 8:00 a.m. to 5:00 p.m.
Travel: Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives
About the Company
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.
Lonza is a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing.
