Director, Operations
$198,900–$232,050 year
RemoteUnited States
Job Summary
Develop and execute the operational readiness strategy for a U.S. growth investment project supporting small molecule drug substance manufacturing. Serve as the primary Operations representative throughout facility design, construction, commissioning, qualification, validation, start-up, and operational handover to ensure GMP compliance and inspection readiness. Lead operating model development, staffing plans, training strategy, and risk mitigation for technology transfer and product introduction. Define the future manufacturing organization, including workforce planning, shift models, and governance processes, while partnering with Engineering, Quality, and EHS teams to integrate operational requirements. Build a high-performing operations organization and provide readiness updates to senior leadership. Full-time role with a Monday–Friday schedule from 8:00 a.m. to 5:00 p.m., with a base salary ranging from $198,900 to $232,050. 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.
Required Qualifications
- Bachelor's degree in engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related discipline
- 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
- 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 in containment-intensive manufacturing environments (e.g., HPAPI containment, isolators, contained material handling)
- Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve
- Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives
Desired Qualifications
- Advanced degree
- 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
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