Director, Operations

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

📋 Description

• Develop and implement the operational readiness strategy for a designated U.S. growth investment project focused on small molecule drug substance manufacturing.

• Oversee operational readiness initiatives, including the development of operating models, staffing plans, training strategies, and start-up preparations.

• Define the future state of the manufacturing organization, encompassing workforce planning, organizational structure, shift models, governance processes, and operational accountability.

• Serve as the Operations representative during facility and process design to ensure that manufacturing requirements are integrated into equipment, automation, process flow, and facility decisions.

• Collaborate with Engineering, MSAT, Quality, Automation, and EHS teams throughout the project execution phase.

• Ensure manufacturing readiness and compliance with GMP through activities related to commissioning, qualification, validation, inspection preparedness, and operational excellence.

• Lead readiness efforts for technology transfer, process implementation, and product launch in small molecule manufacturing programs.

• Identify, evaluate, and address operational, technical, and project risks.

• Build and nurture a high-performing operations organization.

• Provide 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 field.

• 12+ years of leadership experience in pharmaceutical or API manufacturing, covering Operations, Manufacturing, Technical Operations, or similar functions.

• Proven experience in supporting or leading small molecule drug substance manufacturing operations, preferably in API, HPAPI, or complex chemical manufacturing settings.

• Background in commercial manufacturing, technology transfer, validation, and operational readiness.

• Experience in managing major capital projects, facility expansions, greenfield or brownfield investments, manufacturing start-ups, or large-scale growth initiatives.

• In-depth knowledge of GMP manufacturing operations, regulatory requirements, process validation, commissioning, qualification, inspection readiness, and process safety principles in API or chemical manufacturing.

• Demonstrated leadership in cross-functional teams and ability to influence stakeholders across Engineering, Manufacturing, Quality, MSAT, Automation, EHS, HR, Finance, and Project Management.

• Proven track record in building organizations, nurturing talent, and creating sustainable operating models within complex manufacturing environments.

• Excellent communication, strategic planning, problem-solving, and change management skills.

• Flexibility and willingness to relocate to an East Coast or Midwest U.S. site as project needs change.

• Willingness to travel to EMEA and NA approximately 25–30% of the time.

• Preferred experience in HPAPI, complex chemical synthesis, chemical process manufacturing, or containment-intensive manufacturing environments.

• An advanced degree is preferred.

🏝️ Benefits

• Performance-related bonus.

• Medical, dental, and vision insurance.

• 401(k) matching plan.

• Life insurance.

• Short-term and long-term disability insurance.

• Employee assistance programs.

• Paid time off (PTO).