Director, Operations - API

About this role

Job Description

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.

At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.  

Job Purpose: The Director, IPT Leader, API provides leadership, technical and operational expertise to the Integrated Process Team (IPT) supporting the API manufacturing value stream at the Elkton, VA site. This role is accountable for shaping the future operating model for our new small molecule pharmaceutical manufacturing facility, including project and site readiness, organizational design, and the establishment of operating rhythms, governance, IPT culture, Ways of Working, and performance standards. In the early project phases, the incumbent will lead strategic and tactical planning, cross-functional coordination, and project management activities required to support successful site build-out and operational ramp-up. As the site matures, the role will transition into full IPT leadership, accountable for safe, compliant, reliable, and efficient API operations, delivery performance, continuous improvement, stewardship, and people development.  The incumbent serves as a member of the site leadership team and ensures alignment of site priorities with divisional and company strategies.

Primary Responsibilities: Site Leadership and Strategy • 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.

Future-State Operating Model and Ramp-Up • 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.

Operations Excellence and Delivery • 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.

Financial Stewardship • 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.

Quality and Safety Stewardship • 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.

People Leadership • 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

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