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Catalent

Clinical Production Specialist

LocationPhiladelphia, PA
Work modeon-site
Typefull-time
Company size10,000+ people
First seen1w ago
Last seen1d ago
Clinical Production Specialist
About the company
Catalent’s Philadelphia, Pennsylvania site serves as the company’s North American Center of Excellence for clinical supply packaging, delivering comprehensive, end‑to‑end support for global clinical trials across multiple therapeutic modalities. The site provides integrated services including direct comparator sourcing, blinding and manufacturing, primary and secondary packaging, storage and distribution, and clinical returns management, enabling efficient and compliant trial execution. It also plays a growing role in supporting biologic as well as cell and gene therapy programs, with enhanced cold‑chain and cryogenic handling capabilities designed to meet the complex requirements of advanced therapies. As a critical hub within Catalent’s global clinical supply network, the Philadelphia site helps sponsors accelerate development timelines while maintaining the highest standards of quality, flexibility, and regulatory compliance.
Our Philadelphia site is located in the Bensalem/Northeast Philadelphia area.
About the role
We have an opportunity for a Clinical Production Specialist to join our team. In this role, you will oversee the execution, training, and supervision of clinical production staff within a specific clinical packaging batch record operation. You will ensure safety, quality, production rates, material reconciliation, and adherence to timelines. This position requires knowledge of clinical applications such as randomization schedules, open label, blind labeling, study collation, and treatment groups. The work involves multiple packaging operations including blister cards, over-encapsulation, bottle filling, pouching, labeling, kit assembly, and distribution.
Shift: Monday - Friday, 3:45pm-12:15am (2nd Shift)
Location: Philadelphia, PA
100% Onsite
The Role
Responsibilities
•
Monitor, organize, and perform all functions related to packaging of clinical trial supplies, ensuring compliance with Good Manufacturing Practices, Standard Operating Procedures, and regulatory requirements (FDA, DEA, OSHA) for assigned Production Batch Records
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Oversee assigned batch record operations in primary and secondary production rooms with various pharmaceutical packaging equipment such as automated bottle lines, form-fill-seal equipment, card sealing, vial and ampoule labelers, pouch equipment, and medical device tray sealing
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Manage production involving manual and automated application of randomized labels on bottles, cards, cartons, kits, vials, syringes, and ampoules; Maintain and order personnel, safety, disposable, and support packaging supplies for assigned production room operations
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Ensure correct placement of multiple look-alike product combinations in blister units, cards, and bottles; Handle packaging of refrigerated and frozen clinical trial material
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Accurately enter data in batch records and logbooks; Review completed manufacturing and packaging batch records in a timely manner
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Ensure security, accountability, and reconciliation of controlled substances in assigned clinical production operations
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Manage staging, reconciliation, and inventory label generation in the ERP system (JD Edwards)
•
All other duties as assigned
The Candidate
Minimum Requirements
•
High School Diploma or GED; Associate Degree preferred
•
1+ years of clinical, contract, or production experience
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Must have computer proficiency to include the use of Microsoft Word
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Working knowledge of current Good Manufacturing Practices, DEA, and OSHA regulations
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Knowledge of packaging equipment in a Just-in-Time environment
Preferred Skills & Background
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Experience in clinical trial manufacturing and packaging
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Experience with JD Edwards or similar ERP systems
Why You Should Join Catalent
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Defined career path with annual performance reviews and feedback
•
Diverse and inclusive culture
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Opportunities for career growth within an organization dedicated to improving lives
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Competitive paid time off plus 8 paid holidays
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Community engagement and green initiatives
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Medical, dental, and vision benefits effective from day one
•
Tuition reimbursement program
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 work.
Visit Catalent Careers to explore career opportunities.
Legal
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 [email protected]. 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 [email protected] for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.
Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.
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