Product Development Operations Supervisor

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

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.

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