What are the responsibilities and job description for the Manager, Product Development Operations position at Catalent?
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 able to complete a medical evaluation with satisfactory results. The medical evaluation is conducted via an external vendor assigned by Catalent.
Why You Should Join Catalent
Competitive medical benefits and 401K
152 hours of PTO 8 Paid Holidays
Dynamic, fast-paced work environment
Opportunity to work on Continuous Improvement Processes
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
