Product Development Operations Supervisor

NoxPharm

Greenville (NC)

On-site

USD 90,000 - 130,000

Full time

47 hours ago
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Benefits offered by this job

Competitive Paid Time Off
Medical, dental, and vision benefits
Tuition reimbursement
Onsite fitness center
Perkspot discounts
Employee Resource Groups

Job summary

Catalent's Greenville, NC site is a major provider of oral solid dose development and manufacturing, offering end-to-end services from development to market. This role supervises daily Pharmaceutical Development and Clinical Manufacturing operations, ensuring safe, compliant, and on-time production with a focus on data integrity and quality systems.

Required are 5+ years in pharmaceutical development or manufacturing, strong leadership, and the ability to coordinate with multiple functions to

Qualifications

  • Leadership of regulated manufacturing teams
  • Experience ensuring cGMP compliance and data integrity
  • Ability to coordinate with multiple site functions and document control

Responsibilities

  • Plan, coordinate, and supervise Pharmaceutical Development and Clinical Manufacturing activities
  • Lead daily production execution and ensure batch records and logs meet cGMP requirements
  • Provide supervision, coaching, and training to production personnel
  • Coordinate with cross‑functional site teams to meet timelines and client commitments
  • Maintain readiness of manufacturing suites, equipment, materials, and documentation
  • Support development, engineering, qualification, and validation protocols
  • Assist in deviations, investigations, CAPAs, and recurrence prevention
  • Other duties as assigned

Skills

Team leadership
Quality systems
cGMP compliance
Cross-functional collaboration
Safety awareness

Education

Bachelor’s degree in Pharmaceutical Sciences or related
Associate degree with relevant experience
High school diploma with relevant experience

Job description

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.

Position Summary

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, 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
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
  • The 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 preferred
  • Experience in a CDMO, client‑facing, development‑to‑commercial, or highly cross‑functional pharmaceutical manufacturing environment preferred
Why You Should Join Catalent
  • Positive and fast‑paced working environment focusing on continual improvement and innovation.
  • 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 wor

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