The Clinical Coordinator position as part of the Pre-Production department is responsible for assisting the coordination of activities related to the preparation, procurement, packaging, labeling and assembly of clinical trial materials. The role of a Clinical Coordinator is critical to the end user which are our patients. It directly affects patients’ risk and safety if batch records are incorrect or not on time. Quality, Safety and Right First Time and on-time delivery is a must to be successful in this role!

This role will reside at our Philadelphia, PA Clinical Supply Services site. This is a first shift, hourly position.

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:

• Assist Project Managers with development of clinical, stability, and commercial packaging protocols and materials
• Create batch records based on project source documentation from Project Management including primary, secondary labeling and kitting and assembly
• Interact with Production, Quality Assurance, Label Control, and Packaging Engineering personnel to communicate project requirements and gather appropriate paperwork for batch records
• Item Master identification and creator of request forms, JD Edwards Router, BOM, Purchase Order, and Work Order creation, GSA set up.
• Create Change Orders and drive resolution to changes required during production.
• Client interaction and communication to facilitate responses to customer questions and provide batch records etc., as required.
• Support project timelines as directed by Management ensuring that key project millstones are met and projects progress in a satisfactory and timely manner.
• Work with Label Control to obtain item numbers for labels and randomization copies for batch records

The Candidate:

• Requires a high school diploma or GED; Associates or Bachelor’s degree is preferred
• At least one year of experience working in a cGMP environment is preferred; at least one year experience working a pharmaceutical environment is preferred
• Experience working in preparation of packaging batch records, packaging, labeling, assembly and distribution of clinical trial materials is preferred
• Must have ability to work with minimal supervision, must be detail-oriented and organized, with an emphasis on quality

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 19 days of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Employee Stock Purchase Program
• 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.