Pre-Production and Label Control Manager

Manager Pre-Production and Label Control

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 Manager Pre-Production and Label Control. This Manager Pre-Production and Label Control is responsible for leading teams responsible for pre-production activities. Specifically, study set-up, batch record and protocol generation, design, creation, printing, receipt / control and destruction of primary and secondary packaging labels utilized in packaging and distribution of stability, analytical, commercial, and clinical trial material. The responsibilities include oversight of the creation of and control of randomization for clinical trial studies. The scope of this role is the Philadelphia site Pre-Production and Label Control.

The Technical Services team at Philadelphia is responsible for Pre-Production Operations to support on-time clinical and commercial packaging activities, management of deviations and complaints site-wide and site-wide training. The Technical Services Team works closely with other functional departments such as Quality, Project Management and Engineering. The team focuses on preparation of technical documentation, production readiness, execution excellence, compliance, and GMP investigations, New Hire Onboarding and building continued capability within the site.

This is a full-time role position : Monday-Friday -Day Shift. Onsite Role.

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

• Build, maintain and motivate a team capable of achieving technical targets to service customers on time and right first time. Lead the teams responsible for study set up, batch records generation, label receipt, creation / design, inspection, receipt / control, storage, destruction, and release
• Communicate Batch Record and Label status to other pertinent functional areas. Liaise directly with Scheduler, Warehouse and Production to ensure proper staging of materials per timelines
• Partner with Packaging Engineering on label design requirements. Monitor and report on relevant KPIs. Adhere to and manage project timelines to ensure the batch records, label proofs, randomizations and printed labels are ready within the committed timeframe
• Collaborate with Project Managers to ensure job readiness per committed timelines. Ensure compliance with all FDA (GMP / GCP) regulations. Implement standard operating procedures (SOPs) and training documentation
• Ensure efficiency and cost effectiveness through optimum utilization of resources and ongoing evaluation and improvement of methods and systems. Develop procedures and techniques to optimize operations and effectively service internal and external clients
• Lead investigations for timely submissions and ensure appropriate CAPA and close out. Management responsibilities include professional development, performance appraisals and employee counseling direct reports.
• Proven leadership skills and track records of success in managing technical groups (direct reports) and teams. Demonstrated leadership skills in coaching, managing and mentoring staff. Demonstrated leadership track record in developing high performance staff to fully explore their potential
• Analyze staffing requirements related to business needs and forecasts. Coach staff on management of their departmental personnel including planning, assigning and directing work, addressing complaints and resolving problems.
• Demonstrate professional leadership and commitment in administration of company values. Perform related duties, special projects and / or other functions as required
• All other duties as assigned

The Candidate

Why you should join Catalent :

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.