Director, Operations - API

ALKU; Elkton (VA); On-site; USD 180,000 - 280,000; Full time

Job summary

ALKU's Director, Pharmaceutical Operations - API at Elkton, VA leads the IPT for the new small molecule API facility, shaping the future operating model, site readiness, governance, and performance standards.

This role guides strategic planning, cross‑functional coordination, and ramp‑up activities, transitioning to full IPT leadership focused on safe, compliant, reliable operations and continuous improvement across the site.

Qualifications

• Bachelor’s degree in a science/engineering field; Master’s preferred.
• 10+ years in pharmaceutical or regulated manufacturing environments.
• Leadership across Manufacturing, Technical Operations, Quality, Engineering, or Production Planning.
• Experience with cGMP, regulatory readiness, safety/environmental practices.
• Proven ability to lead in complex, multi-priority environments.

Responsibilities

• Lead Site Leadership Team alignment of IPT priorities with site/company strategy.
• Develop future-state operating model and ramp-up plans for Elkton API operations.
• Ensure safe, compliant, reliable API operations and RFT performance.
• Drive lean thinking, continuous improvement, and cost stewardship.
• Coach and develop leaders within the IPT and coordinate cross‑functional teams.

Skills

Leadership

Cross-functional collaboration

Strategic planning

Project management

Lean Six Sigma

Change leadership

Communication

Education

Bachelor’s degree

Master’s degree

Job description

Director, Pharmaceutical Operations - API

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 maturing, 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, 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.

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.
• 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.