SUMMARY/OBJECTIVE:
The Senior Director, Operations is responsible for leading day-to-day operational execution across manufacturing, packaging, project management, facilities, and warehouse functions within a cGMP, CDMO, or CMO environment. This role translates company strategy into operational plans, drives performance against key metrics, and ensures safe, compliant, and efficient delivery of client programs. The Senior Director partners closely with Quality, Research & Development, Operations, Logistics, Finance and Business Development to support growth, client satisfaction, and inspection readiness.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide operational leadership and oversight for both U.S. and Ireland-based operations teams, ensuring alignment of processes, priorities, and performance expectations across sites.
- Lead daily operations across manufacturing and packaging services, ensuring schedule adherence, quality, and throughput.
- Own operational performance metrics (e.g., OTIF, right-first-time, labor utilization, cost control, and equipment performance).
- Translate strategic objectives from executive leadership into executable operational plans and priorities.
- Provide leadership and development for operations managers and cross-functional teams.
- Partner with Project Management to align production schedules with client timelines and contractual commitments.
- Ensure compliance with cGMP, FDA, DEA (as applicable), and company quality systems; support internal and external audits.
- Drive continuous improvement and operational excellence initiatives, including lean practices and waste reduction.
- Collaborate with Quality on deviation investigations, CAPAs, and risk mitigation actions.
- Support client onboarding, tech transfer, and scale-up activities to ensure successful execution.
- Work with Facilities and Engineering to optimize equipment utilization, maintenance planning, and capacity expansion.
- Collaborate with Warehouse teams to ensure material availability and inventory accuracy.
- Provide operational input during new business assessments and client proposals.
- Maintain effective communication with senior leadership on performance, risks, and resource needs.
- Comply with all company and site policies and procedures and perform other duties as assigned
QUALIFICATIONS AND EXPERIENCE:
- Bachelor’s degree required (Engineering, Life Sciences, or related field preferred).
- 8–12+ years of experience in cGMP pharmaceutical manufacturing and/or packaging environments, including at least 5 years supporting clinical and commercial manufacturing and packaging operations.
- 5+ years of progressive leadership experience managing operations teams.
- Experience in a CDMO/CMO or multi-client manufacturing environment required.
- Demonstrated success leading regulatory inspections and client audits.
- Strong understanding of pharmaceutical packaging, production planning, and operational controls.
COMPETENCIES/SKILLS:
- Strong operational leadership and execution mindset.
- Excellent analytical, problem-solving, and decision-making skills.
- Ability to interpret data and drive performance improvements.
- Effective communication and stakeholder management skills.
- Financial acumen with experience managing budgets and operational costs.
- Ability to lead cross-functional teams in a fast-paced CDMO environment.
- High integrity, professionalism, and accountability
SUPERVISORY RESPONSIBILITIES:
Yes. Typically includes Production/Packaging Managers, Warehouse leadership, Facilities leadership, Project Management and other operations personnel as assigned.
WORK ENVIRONMENT:
Hybrid office and manufacturing environment; routine presence on the production floor required.
SCHEDULE:
On-site 5 days per week in Cranbury, NJ office
SALARY:
$190,000 - $240,000
PHYSICAL DEMANDS:
Combination of office-based work and time in warehouse/manufacturing areas. Ability to stand, walk, and move through production areas as needed.
TRAVEL:
Up to 20–30% travel may be required based on client and business needs.
