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Clinical pack & label outsourcing manager
Requisition ID: 1700201080W
Clinical Pack & Label outsourcing manager
Janssen Research and Development, LLC, a member of the Johnson and Johnson
Family of Companies, is recruiting for a Clinical Pack & Label outsourcing
manager to be located in Beerse, Belgium.
Janssen research and Development, LLC develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders and reproductive medicine.
The Clinical Pack & Label outsourcing manager is supporting the external partner for pack and label operations as well as supporting the engineering aspects of technology transfers of pack & label processes from CSC P&L internal to external partners. He/ She will start from the detailed knowledge of the Pack & Label operations (internal or external). The individual will be the primary contact for P&L at the external partner. He/she will review the operation instructions and the label design requirements for the specific orders at the external partner and then follow up on the progress of the project together with the rest of the PDMS team to assure timely release and distribution of the clinical material to the clinical site.
The clinical Pack & Label
outsourcing manager is coordinating and has overview of all EU and Asia
outsourcing activities with different partners.
The Clinical Pack & Label outsourcing managers activities include, but are not limited to the following:
Knowing the capabilities for primary and secondary packaging and labelling, blistering and bottling format parts, ambient, cold and frozen storage capacity.
Optimizations and/or changes to existing equipment, follow-up on testing and documenting changes.
Requesting quotations and gathering management approval for over-encapsulation and P&L activities.
Preparing technical agreements, execution, planning, procurement, compliance, auditing and KPI tracking
Transfer of operating instructions from internal site to external partner, follow-up on testing and Documentation to support clinical pack & label operations
Label design and batch doc review and approval
Initiate root cause investigation in case of issues and defining corrective actions with support of Janssen CSC experts.
A minimum of a Bachelor’s degree is required. A degree in pharmacy, mechanical, packaging or chemical engineering or by experience are preferences. A minimum of 3 years related work experience in the FDA regulated industry is required. A minimum of 15 years related work experience in a clinical supply environment is required. Experience with project management related to clinical supplies is preferred.
J&J standards and guidelines is preferred. The successful candidate must possess or be able to build an excellent internal and external network of engineering and clinical supply specialists. Excellent communication skills, both verbal and written, to effectively collaborate in a global and cross functional environment is a desired.
This position may require up to 20% domestic or international travel, as needed by business. This position will be based in Beerse, Belgium.
Janssen Pharmaceutica N.V. (7555)