Production Supervisor

Production Supervisor

Position Summary

Catalent Pharma Solutions in Philadelphia, PA is hiring a Production Supervisor. The Production Supervisor is responsible for training, monitoring and supervising clinical production staff. Responsible for employee assignments, safety, quality, production rates, material reconciliation, production reports, timelines and union policies. This position requires a working knowledge of clinical applications regarding study phases I through IV, randomization schedules, open label, blind labeling, dose titration, double blind, double dummy, study collation and treatment groups.

This is a full-time position: Monday - Friday, 2nd Shift.

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID safe storage labels for your studies. Single panel and Peel-ID safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

• Monitors, organizes and performs all functions associated with packaging of clinical trial supplies and assures compliance to good manufacturing practices, standard operating procedures, Food and Drug Administration, Drug Enforcement Agency and Occupational Safety and Health Administration rules and regulations.

• Works closely with Project Management to establish manufacturing and packaging protocol section of batch record for ongoing and future studies.

• Oversees 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 contact.

• Develops, reviews and edits related production standard operating procedures (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.

• Responsible for daily employee training. Review and approval of production staff vacation and personal days, along with leave of absence requests.

• All other duties as assigned.

The Candidate

• High school diploma or general education diploma is required.

• Bachelor of Science Degree in Health/Chemistry/Pharmacy related field is preferred.

• Minimum of 5 years Clinical, contract or production experience is preferred.

• Clinical Trial Manufacturing and Packaging experience is preferred.

• Computer literate (Microsoft Word), JD Edwards experience or similar enterprise resource planning systems preferred.

• Working knowledge of current good manufacturing practices, Drug Enforcement Agency and Occupational Safety and Health Administration rules and regulations preferred.

• Leadership and team building skills. Demonstrate ability to train, motivate, direct and supervise production personnel. 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.

• Knowledge of packaging equipment in a Just-in-Time environment. Proven ability to develop Standard Operating Procedures.

• Individual will be required to stand and/or sit for long periods of time, occasionally lift 0-15 pounds; specific vision requirements include reading of written documents and frequent use of computer.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• 152 hours of PTO + 8 paid holidays

• Several Employee Resource Groups focusing on diversity & inclusion

• Dynamic, fast-paced work environment

• 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

• Competitive salary with possible bonus potential

• Community engagement and green initiatives

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement - Let us help you finish your degree or earn a new one!

• GymPass program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (~~~) to explore career opportunities.

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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ~~~ for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (~~~) .