Pre-Production and Label Control Manager
Pre-Production and Label Control Manager
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Job Description
Manager Pre-Production and Label Control
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 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 andcompliance 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
- Required a High School Diploma or Equivalent with 10 years of relevant experience preferably in a pharmaceutical manufacturing setting; OR Bachelors Degree with minimum of 5 years relevant experience preferably in a pharmaceutical manufacturing setting.
- Experience managing people is required
- Demonstrated ability to motivate and lead others while working alongside them to complete tasks to reach organizational goals highly 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 50 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
