Product Development Operations Supervisor

Catalents Greenville North Carolina site is a major oral solid dose development and manufacturing campus delivering endtoend 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 fitforscale infrastructure potent handling capabilities and a strong regulatory track record making it a critical part of Catalents 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 sites 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

• Bachelors 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 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 7000 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.

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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 . 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.

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