Production Operations Director

Production Operations Director

Position Summary

The Production Director is responsible for providing key leadership, direction, organization, management, monitoring, and cGMP compliance of the roles, activities, and proceedings of Manufacturing to ensure the successful, cost effective, timely, and safe processing of client projects. This position is responsible for all of cGMP Manufacturing and will serve as a member of the site leadership team.

Essential Functions

• Provide strategic and operational leadership across all cGMP manufacturing activities, ensuring safe, compliant, and efficient operations that meet client delivery timelines, quality expectations, and cost objectives.
• Develop and execute manufacturing strategies and operational excellence initiatives aligned with site objectives and MedPharm’s growth as a CDMO.
• Partner with senior leadership to translate short and long‑term business strategies into executable manufacturing plans, capacity forecasts, and investment priorities.
• Establish, maintain, and continuously improve manufacturing systems, procedures, and controls to ensure compliance with regulatory requirements and adherence to MedPharm’s quality standards (SOPs), and client commitments.
• Collaborate closely with MS&T, Quality, Engineering, EHS, Supply Chain, and Program Management to proactively troubleshoot manufacturing challenges and enable robust, scalable, right‑first‑time manufacturing.
• Provide technical and operational leadership to support complex drug product manufacturing, ensuring processes are efficient, scientifically sound, and inspection‑ready.
• Lead and develop high‑performing manufacturing teams through effective workforce planning, hiring, training, performance management, succession planning, and talent development, in partnership with Human Resources.
• Foster a culture of accountability, engagement, and continuous improvement through clear communication of expectations, priorities, policies, and operational goals.
• Ensure manufacturing personnel maintain the appropriate technical competence and training required to meet cGMP, safety, and quality requirements.
• Own manufacturing performance by ensuring labor, equipment, and process KPIs are achieved; prioritize initiatives and coordinate improvement efforts across all production areas.
• Optimize workforce levels, facility utilization, and material consumption to meet production demands while achieving budgetary and cost targets.
• Lead cross‑functional planning to define project scope, timelines, resources, and budgets necessary to deliver client programs and internal initiatives successfully.
• Make timely and sound decisions on operational and administrative matters to ensure effective execution of manufacturing objectives and business plans.
• Manage manufacturing budgets and execution schedules, ensuring alignment with corporate timelines, financial plans, and client commitments.
• Address complex operational challenges requiring in‑depth understanding of MedPharm technologies, regulatory expectations, and client delivery models.
• Demonstrate strong influencing and negotiation skills when working with suppliers, service providers, and internal stakeholders on matters impacting manufacturing performance.
• Perform additional duties as required to support site leadership, laboratory management, and overall business objectives.

Supervisory responsibilities :

• Direct Reports: Yes
• Indirect Reports: Yes

Key Relationships (examples: Depts or Individual positions that this position will be working closely with):

• Quality Control
• Quality Assurance
• Project Management
• Production / operations department

Executive Leadership Team

Travel requirements :

• N/A

Education and Experience

• Bachelor’s degree in Engineering, Life Sciences, Manufacturing, or a related field; a Master’s degree (MBA) is preferred.
• 5+ years of leadership experience. Exceptional people/operations leader with proven experience developing and inspiring teams, driving organization health and culture, and successfully navigating change management processes and principles.
• 8+ years manufacturing experience, preferably in a manufacturing setting for pharmaceuticals , under cGMP. Experience in pharmaceutical and/or biotechnology industry is required.
• Working knowledge of end-to-end supply chain preferred including experience with S&OP, Inventory Management, and other associated Supply Chain disciplines.
• Thorough experience with clinical and commercial manufacturing.
• Direct experience working for or with contract manufacturing organization(s) strongly preferred.
• Active participation in regulatory inspections and up to date on compliance requirements.

Knowledge, Skills, and Abilities

• Speaks, writes, listens and presents information in a logical and articulate manner appropriate for the audience
• Is thorough when performing work, conscientious about attending to detail, and uses logical thinking that is well-organized and methodical
• Technically capable of determining the root cause of a problem, offering potential solutions, and working with others to correct the problem
• Responds to changing needs of the business, and personally identifies and champions new ideas for improvement and growth

Physical Demands and Work Environment

While performing the duties of this job, there may be certain physical demands required for the position.

• Requires constant standing, walking, & sitting
• Require frequent carrying, lifting, pushing, & pulling under 20 LBS
• Requires frequent bending & reaching
• Requires occasional twisting
• Requires constant seeing, hearing, & gripping

Other Duties

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.