Manager, Product Development Operations

Manager, Product Development Operations

Position Summary

Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.

The Manager, Product Development Operations oversees  the  daily  production  floor  activities  of  pre-commercial  operations  while  ensuring  that  cGMP requirements  are  met. The Manager, Product Development Operations  role  is  also  responsible  for  supporting  department  leadership  with  staffing,  budgeting, and operator training/performance.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Role

• Provide leadership and day-to-day management of quality, safety and compliance activities for Product Development Operations.

• Support audits/inspections of pharmaceutical development area; lead audit tours and ensure the area is compliant.

• Actively promote a continuous improvement mindset to drive value propositions in Product Development Operations.

• Provide leadership and oversight of Development production floor activities.

• Responsible for GMP compliance and training in all aspects of pre-commercial operations; ensure that production groups are properly trained and employees perform duties according to approved Manufacturing policies, Standard.

• Operating Procedures, guidelines for Safety, and all applicable current Good Manufacturing Practices.

• Provide employees with general supervision as well as development and learning opportunities to promote career growth; ensure ongoing performance and coaching dialogue with team members.

• Evaluate deviations and trends; provide feedback, resolution and implement changes to improve operations.

• Recognize potential problems and provide input on needed corrective action.

• All other duties as assigned.

The Candidate

• Bachelor’s degree in Engineering or science-related field with at least 5 years of pharmaceutical production experience and 2 years of supervisory experience.

• Demonstrated ability to motivate employees and management skills (e.g. business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution).

• Thorough knowledge of cGMPs and other government regulations appropriate to pharmaceutical manufacturing.

• Ability to lift in excess of 50 lbs unassisted.

• Majority of work day is performed while standing, walking, lifting, pulling, pushing.

• Ability to communicate effectively using speech, vision and hearing

• Requires the use of hands for simple grasping and fine manipulations.

• Requires bending, squatting, reaching, pushing, climbing.

• Requires the ability to stand for extended periods of time.

• Some exposure to hazardous chemical and other active chemical ingredients.

• Must be able to use a variety of tools, equipment, and machinery.

• This position requires that a respirator be worn for your safety, and as such, employment is contingent upon being a