Director, Operations - API

Primary Responsibilities

• Serve as a member of the Site Leadership Team and help align IPT priorities with site and company strategy.
• Provide direction to establish tactical and strategic plans that support API ramp-up and long-term operational success.
• Partner across the site and with above-site teams to ensure strong coordination, decision-making, and execution.
• Represent the IPT and the site as needed with internal stakeholders and external partners.
• Lead the development of the future-state operating model for the API operations at Elkton, VA.
• Support site start-up, ramp-up, and operational readiness activities through project leadership and cross-functional coordination.
• Help define organizational structure, organizational culture, operating rhythms, governance, and capability needs for the evolving site.
• Ensure readiness plans, risk assessments, and implementation plans are developed and executed effectively.
• Ensure safe, compliant, and reliable and RFT API operations in support of production and supply objectives.
• Lead operational reviews and daily management routines to maintain visibility to performance, issues, and priorities.
• Drive structured problem solving and the use of performance metrics to identify trends, action plans, and opportunities for improvement.
• Support production planning, resource deployment, and issue resolution to meet site objectives.
• Promote lean thinking and continuous improvement to improve flow, throughput, right-first-time performance, and operational stability.
• Support and/or own budget planning and financial stewardship for the IPT, including operating and capital spend.
• Partner with site leadership to identify opportunities for productivity, efficiency, and cost improvement.
• Ensure resources are allocated effectively to support current and future business needs.
• Promote a strong quality culture and support a state of permanent inspection readiness.
• Ensure cGMP compliance and effective management of deviations, investigations, and corrective actions.
• Partner with Quality, EHS, Engineering, Technical, and Supply Chain teams to support site priorities and maintain strong compliance standards.
• Ensure appropriate training, documentation, and change management practices are in place to support safe and compliant operations.
• Champion a strong safety culture and support risk management activities across the IPT.
• Lead, coach, and develop a team of leaders and contributors to build a high-performing organization.
• Foster a culture of accountability, collaboration, empowerment, and continuous learning.
• Support talent development, succession planning, and ongoing skill-building within the IPT.
• Communicate clearly and regularly to align the team around priorities, expectations, and performance.

Minimum Required Education, Experience

• Bachelor’s degree required. Chemistry, Chemical Engineering, Pharmaceutical Sciences, Engineering, or a related scientific/technical discipline is preferred.
• 10+ years of relevant experience in pharmaceutical or other regulated manufacturing environments.
• Leadership experience in one or more of the following areas: Manufacturing, Technical Operations, Quality Operations, Engineering, and/or Production Planning.
• Experience leading teams with direct and indirect reports.
• Strong knowledge of cGMP, quality systems, regulatory readiness, and safety/environmental practices.
• Demonstrated experience with operational planning, project leadership, or site ramp-up/start-up activities.
• Proven ability to lead in complex environments and manage multiple priorities across functions.
• Strong business acumen and experience with financial stewardship and resource planning.
• Experience applying Lean Six Sigma, continuous improvement, and structured problem-solving tools.
• Effective communication, coaching, and change leadership skills.

Preferred Qualifications

• Master’s degree in Science, Engineering, Business, or a related discipline.
• Experience in small molecule API manufacturing or commercial pharmaceutical operations.
• Prior experience supporting a manufacturing site start-up, transformation, or ramp-up.
• Experience developing future-state operating models, organizational structures, or operational governance systems.
• Lean Six Sigma certification or deep practical application of Lean tools.
• Experience in a highly matrixed global manufacturing environment.
• Demonstrated success in talent development, employee engagement, and succession planning.
• Experience with capacity planning, capital planning, supply planning, and S&OP.
• Familiarity with inspection readiness, deviation management, and broader quality systems in a regulated environment.