Director, API Operations & Site Ramp-Up

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

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.