Clinical Production Specialist

Catalent Pharma Solutions; Philadelphia (Philadelphia County); Presencial; USD 60.000 - 80.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive PTO and holidays

Benefits from day one

Tuition reimbursement

Descripción de la vacante

Catalent’s Philadelphia, Pennsylvania site is seeking a Clinical Production Specialist to oversee packaging of clinical trial supplies and supervise staff within a specific batch-record operation. The role emphasizes safety, quality, and adherence to timelines in a 2nd shift setting.

You will manage multiple packaging operations, including automated bottle lines, form-fill-seal, labeling, and kit assembly, while ensuring accurate data entry and batch record review.

Formación

• Minimum Requirements: High School Diploma or GED; Associate Degree preferred.
• 1+ years of clinical, contract, or production experience.
• Computer proficiency including Microsoft Word.
• Knowledge of current Good Manufacturing Practices (cGMP), DEA, and OSHA regulations.
• Knowledge of packaging equipment in a Just-in-Time environment.

Responsabilidades

• Monitor, organize, and perform all functions related to packaging of clinical trial supplies, ensuring compliance with GMP, SOPs and regulatory requirements (FDA, DEA, OSHA).
• Oversee batch record operations in primary and secondary production rooms with automated packaging equipment.
• Manage production involving manual and automated labeling on bottles, cards, cartons, kits, vials, syringes and ampoules; maintain materials and supplies.
• Ensure correct placement of look-alike products in blister units, cards and bottles; handle refrigerated and frozen clinical material.
• Enter data in batch records and logbooks; review manufacturing and packaging batch records timely.
• Ensure security, accountability, and reconciliation of controlled substances.
• Manage staging, reconciliation, and inventory label generation in the ERP (JD Edwards).
• All other duties as assigned.

Conocimientos

cGMP knowledge

DEA regulations

OSHA regulations

Packaging equipment knowledge

Educación

High School Diploma or GED

Associate Degree

Herramientas

JD Edwards

Microsoft Word

Descripción del empleo

Clinical Production Specialist

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.

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

• 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
• 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
• 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
• Ensure correct placement of multiple look‑alike product combinations in blister units, cards, and bottles; Handle packaging of refrigerated and frozen clinical trial material
• Accurately enter data in batch records and logbooks; Review completed manufacturing and packaging batch records in a timely manner
• Ensure security, accountability, and reconciliation of controlled substances in assigned clinical production operations
• 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
• Must have computer proficiency to include the use of Microsoft Word
• Working knowledge of current Good Manufacturing Practices, DEA, and OSHA regulations
• Knowledge of packaging equipment in a Just-in-Time environment

Preferred Skills & Background

• Experience in clinical trial manufacturing and packaging
• Experience with JD Edwards or similar ERP systems

Why You Should Join Catalent

• Defined career path with annual performance reviews and feedback
• Diverse and inclusive culture
• Opportunities for career growth within an organization dedicated to improving lives
• Competitive paid time off plus 8 paid holidays
• Community engagement and green initiatives
• Medical, dental, and vision benefits effective from day one
• Tuition reimbursement program

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 [e-mail]. 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.

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.