Production Supervisor- 2nd Shift

CatalentPhiladelphia, PA
1dOnsite

About The Position

Production Supervisor Position Summary: Work Schedule: Monday – Friday, 4pm-12:10am. 100% on-site Catalent’s 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation. The Production Supervisor oversees and supports clinical production staff, ensuring safety, quality, and efficiency across all packaging operations. This role manages employee training, assignments, production schedules, and compliance with GMP, union, and safety standards. The position requires hands-on experience with clinical packaging processes, including blister carding, bottle filling, labeling, kit assembly, and handling of controlled substances in a cleanroom environment. The Role Monitors, organizes and performs all functions associated with packaging of clinical trial supplies and assures compliance to GMPs, SOPs, FDA, DEA and OSHA rules and regulations Works closely with Project Management to establish manufacturing and packaging protocol section of batch record for ongoing and future studies Oversee both primary and secondary production areas equipped with various pharmaceutical packaging equipment including but not limited to: automated bottle line, form, fill and seal equipment, card sealing, vial and ampoule labelers, pouch equipment and medical device tray sealing Responsible for production involving manual and automated application of randomized labels on bottles, cards, cartons, kits, vials, syringes and ampoules Responsible for insuring correct placement of multiple look-alike product combinations in blister units, cards and bottles. Responsible for maintaining and ordering personnel, safety, disposable and support packaging supplies Employee performance evaluations, new employee hiring, disciplinary notices, employee termination, according to company guidelines and performance requirements as established in the union contract Develops, reviews and edits related production SOP’s (operational, maintenance, cleaning) in Documentum program. Investigate and prepare out of specification reports and customer complaints related to production in TrackWise program Must review completed manufacturing and packaging batch records in a timely manner. Responsible for handling the packaging of refrigerated and frozen clinical trial material Staging, reconciliation and inventory label generation in ERP system (JD Edwards) All other duties as assigned

Requirements

  • High School Diploma or General Education Diploma is required; Bachelor’s degree preferred
  • 5+ years of Clinical, contract or production experience required; Clinical Manufacturing and Packaging experience preferred
  • Computer literate (Microsoft Word) is required
  • JD Edwards experience or similar ERP systems preferred
  • Working knowledge of relevant cGMPs, DEA and OSHA rules and regulations is preferred
  • Position requires extended periods of standing or sitting, occasional lifting up to 15 lbs, and regular interaction on the temperature-controlled production floor (with gowning required), as well as occasional work in refrigerated (2°–8°C) or freezer (-20°C) environments with appropriate cold gear
  • Willingness to work overtime, frequently in cold environments, and track, monitor and maintain production rates, labor hours and downtime

Nice To Haves

  • Clinical Manufacturing and Packaging experience preferred
  • JD Edwards experience or similar ERP systems preferred
  • Working knowledge of relevant cGMPs, DEA and OSHA rules and regulations is preferred
  • Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

Responsibilities

  • Monitors, organizes and performs all functions associated with packaging of clinical trial supplies and assures compliance to GMPs, SOPs, FDA, DEA and OSHA rules and regulations
  • Works closely with Project Management to establish manufacturing and packaging protocol section of batch record for ongoing and future studies
  • Oversee both primary and secondary production areas equipped with various pharmaceutical packaging equipment including but not limited to: automated bottle line, form, fill and seal equipment, card sealing, vial and ampoule labelers, pouch equipment and medical device tray sealing
  • Responsible for production involving manual and automated application of randomized labels on bottles, cards, cartons, kits, vials, syringes and ampoules Responsible for insuring correct placement of multiple look-alike product combinations in blister units, cards and bottles.
  • Responsible for maintaining and ordering personnel, safety, disposable and support packaging supplies
  • Employee performance evaluations, new employee hiring, disciplinary notices, employee termination, according to company guidelines and performance requirements as established in the union contract
  • Develops, reviews and edits related production SOP’s (operational, maintenance, cleaning) in Documentum program. Investigate and prepare out of specification reports and customer complaints related to production in TrackWise program
  • Must review completed manufacturing and packaging batch records in a timely manner.
  • Responsible for handling the packaging of refrigerated and frozen clinical trial material
  • Staging, reconciliation and inventory label generation in ERP system (JD Edwards)
  • All other duties as assigned

Benefits

  • Defined career path and annual performance review and feedback process
  • Diverse, inclusive culture
  • Positive working environment focusing on continually improving processes to remain innovative
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
  • 152 hours of PTO + 8 paid holidays
  • Several Employee Resource Groups focusing on D&I
  • Dynamic, fast-paced work environment
  • Community engagement and green initiatives
  • Generous 401K match
  • Medical, dental and vision benefits
  • Tuition Reimbursement - Let us help you finish your degree or start a new degree!
  • WellHub- program to promote overall physical wellness
  • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Education Level

High school or GED

Number of Employees

5,001-10,000 employees

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