Product Development Operations Supervisor

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.

Monday
- Friday 8:00am-5:00pm

Location:

Greenville, NC
100% Onsite

• 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, elevate, 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

• Bachel…