Clinical Packaging Manager
Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
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 Pharma Solutions in Philadelphia is hiring a Clinical Packaging Manager. The Packaging Manager is responsible for providing leadership to ensure that the product is delivered to clients and patients on time and to quality standards. Packaging operations are executed to achieve the operational objectives in accordance with Packaging standards and the Quality Management System. This role works collaboratively across departments to drive operational excellence and to identify and execute continuous improvement projects increasing Packaging performance and compliance. The packaging operations team at the Philadelphia facility is responsible for overseeing pharmaceutical clinical and commercial packaging operations, including drug product and DEA controlled substance. Primary and secondary packaging operations are executed at ambient through frozen temperature conditions in three buildings across campus.
This is a full-time role position: Monday-Friday -Day shift. Onsite
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
Accountable for timely, compliant and effective execution of Packaging operations
Responsible for maintaining and reporting operational performance metrics
Responsible for identification and implementation of improvement opportunities for established processes, procedures, and training to maintain robust processes and high functioning teams
Partner with Validation and Engineering to identify, implement and effectively use Packaging Equipment and Automation technology
Maintain packaging facilities and supplies
Manage employees according to company guidelines and performance requirements as established in the union contract
Complete and support Deviation and Complaint investigations and identify and execute effective CAPA
Support client and regulatory audits and resolution of observations
Responsible for interfacing with the clients and managing internal communication to sustain and enhance the Client relationships
Provide training, mentoring and development of direct and indirectly reporting Packaging employees
All other duties as assigned;
The Candidate
Requires a Bachelor’s Degree with at least 7 years of experience; OR a High School Diploma/GED with at least 12 years of experience
Three years of Supervisory and/or management experience required
Detailed knowledge of Pharmaceutical Packaging process and Manufacturing experience and Knowledge of packaging equipment operations highly desired
Understanding of clinical study packaging and labelling management preferred
In-depth knowledge of GMP packaging requirements desired
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.
Required Leadership skills include excellent interpersonal and communication skills with all levels of stakeholders, the strong ability to lead, mentor, train, motivate, direct and empower a team, influence and lead change, contribute strategic, analytical insight for problem solving and partner with cross functional teams to identify gaps, develop and implementation of continuous improvement ideas
Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required
Individual may be required to sit, stand, walk regularly and occasionally lift up to 15 pounds
Why you should join Catalent:
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
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.
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.
