Director, Operations

Lonza•Walkersville, MD

13d•$198,900 - $232,050•Remote

About The Position

We are seeking a Director, Operations to develop and execute the operational readiness strategy for an assigned U.S. growth investment project supporting small molecule 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 facility is GMP-compliant, inspection-ready, and capable of supporting reliable clinical and commercial manufacturing from day one.

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.
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
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 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

Nice To Haves

Experience with HPAPI, complex chemical synthesis, or chemical process manufacturing is preferred
Experience in containment-intensive manufacturing environments (e.g., HPAPI containment, isolators, contained material handling) preferred

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