drjobs Clinical Packaging Manager

Clinical Packaging Manager

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Job Location drjobs

Philadelphia, PA - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

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 206878 square-foot facility located in the Philadelphia area is Catalents 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 andcompliance 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 Bachelors 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 7000 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 . 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.


Required Experience:

Manager

Employment Type

Full-Time

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