Product Development Operations Supervisor

Catalent Pharma Solutions; Greenville (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition Reimbursement

Paid time off and holidays

Career growth opportunities

Diversity and inclusion programs

Wellness programs and onsite fitness

Job summary

Catalent Pharma Solutions in Greenville, NC, is seeking a seasoned supervisor to lead Pharmaceutical Development and Clinical Manufacturing operations, ensuring safe, right‑first‑time production in support of oral solid dose programs.

You will supervise batch records, coach staff, and coordinate cross‑functional teams to meet project timelines while upholding cGMP, safety, and quality systems; this is an onsite role, Monday–Friday.

Qualifications

• Bachelor’s degree plus 5+ years in pharmaceutical development or clinical manufacturing.
• Ability to lead teams in a regulated environment with staff development.
• Ability to lift >40 lbs and perform physical requirements.

Responsibilities

• Plan, coordinate, and supervise Pharmaceutical Development and Clinical Manufacturing activities, including development, clinical, engineering, registration‑support, and scale‑up batches.
• Lead daily production execution to ensure batch records, protocols, logbooks, forms, procedures, and other controlled documents are completed accurately, contemporaneously, and in accordance with cGMP and Catalent data integrity expectations.
• Provide direct supervision, coaching, training, and performance support for production team members to promote safe, compliant, and consistent execution.
• Coordinate daily priorities with cross‑functional site teams to support project timelines, client commitments, production readiness, and effective communication.
• Ensure manufacturing suites, equipment, materials, and documentation are maintained in a state of readiness and compliance with site procedures, safety standards, quality expectations, and regulatory requirements.
• Supervise equipment set‑up, changeover, cleaning verification, material staging, line clearance, area readiness, batch execution, in‑process sampling, and post‑run documentation.
• Support development, engineering, qualification, process characterization, cleaning, and validation protocols, including reliable collection and submission of required samples and supporting records.
• Other duties as assigned

Skills

Leadership

Regulatory compliance

cGMP knowledge

Cross-functional collaboration

Safety training

Education

Bachelor’s degree in Pharmaceutical Sciences, Engineering, Industrial Technology, Business Administration, Operations

Associate degree in related discipline

High school diploma with related experience

Job description

Position Summary

Catalent’s Greenville, North Carolina site is a major oral solid dose development and manufacturing campus, delivering end‑to‑end, turnkey solutions from formulation development through commercial manufacturing and packaging. The site specializes in oral solid dosage forms, supported by integrated formulation expertise, comprehensive analytical services, and scalable manufacturing capabilities designed to support both commercial products and potent or targeted therapies, including orphan drugs. Backed by more than $100 million in recent investments, the Greenville operation features fit‑for‑scale infrastructure, potent handling capabilities, and a strong regulatory track record, making it a critical part of Catalent’s global network for advancing complex oral drug programs from development to market.

This position supervises daily Pharmaceutical Development and Clinical Manufacturing operations in support of oral solid dose development, clinical trial material manufacture, scale‑up, engineering, and registration batches. This role provides frontline leadership to ensure production activities are planned, staffed, documented, and executed safely, right‑first‑time, and in compliance with cGMP, quality systems, EHS requirements, client expectations, and applicable regulatory standards. The role coordinates closely with Product Development, Quality, Project Management, Supply Chain, Facilities and Engineering, Maintenance, Technical Services, and Commercial Operations to support project timelines, production readiness, and reliable client delivery.

Shift: Monday- Friday 8:00am-5:00pm Location: Greenville, NC 100% Onsite

The Role

• Plan, coordinate, and supervise Pharmaceutical Development and Clinical Manufacturing activities, including development, clinical, engineering, registration‑support, and scale‑up batches
• Lead daily production execution to ensure batch records, protocols, logbooks, forms, procedures, and other controlled documents are completed accurately, contemporaneously, and in accordance with cGMP and Catalent data integrity expectations
• Provide direct supervision, coaching, training, and performance support for production team members to promote safe, compliant, and consistent execution
• Coordinate daily priorities with cross‑functional site teams to support project timelines, client commitments, production readiness, and effective communication
• Ensure manufacturing suites, equipment, materials, and documentation are maintained in a state of readiness and compliance with site procedures, safety standards, quality expectations, and regulatory requirements
• Supervise equipment set‑up, changeover, cleaning verification, material staging, line clearance, area readiness, batch execution, in‑process sampling, and post‑run documentation
• Support the site’s oral solid dose operations, including blending, milling, granulation, fluid bed processing, compression, encapsulation, coating, potent compound handling, controlled substance handling, and related development or clinical manufacturing processes, as applicable
• Provide input on equipment needs, set‑up strategies, containment controls, facility readiness, and production workflows to support safe and effective development, clinical, and scale‑up manufacturing
• Recognize, escalate, and help resolve safety, material, documentation, process, equipment, containment, compliance, and execution issues; support deviations, investigations, CAPAs, and recurrence prevention as appropriate
• Support development, engineering, qualification, process characterization, cleaning, and validation protocols, including reliable collection and submission of required samples and supporting records
• Other duties as assigned

The Candidate Minimum Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Engineering, Industrial Technology, Business Administration, Operations, or related discipline with at least 5 years of relevant pharmaceutical development, clinical manufacturing, oral solid dose, or pharmaceutical production experience
• Associate degree in a related discipline with at least 6 years of relevant experience
• High school diploma or equivalent with at least 7 years of relevant experience
• Demonstrated success leading teams in a regulated environment, including employee development, performance management, cross‑functional collaboration, investigation support, and execution of business objectives in compliance with quality and regulatory requirements
• Ability to lift in excess of 40 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.

Preferred Skills and Background

• Experience with oral solid dose operations, clinical trial material manufacturing, scale‑up, technical transfer, process validation, potent compound handling, controlled substance handling, or cGMP production
• Experience in a CDMO, client‑facing, development‑to‑commercial, or highly cross‑functional pharmaceutical manufacturing environment

Why You Should Join Catalent

• Competitive Paid Time Off plus 8 paid holidays
• Medical, dental, and vision benefits effective day one of employment
• Tuition Reimbursement to help you finish your degree or earn a new one
• Engaging site‑based activities such as Music Bingo, Puppy Supply Donation Program, and seasonal events
• Employee Resource Groups promoting Diversity and Inclusion
• Green initiatives and community engagement programs including highway clean‑up
• Defined career path with annual performance reviews and growth opportunities
• WellHub program promoting physical and mental wellness, including onsite fitness center
• Exclusive discounts through Perkspot from over 900 merchants

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 including the job number, title and location to [e-mail]. 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.