The Operations Planning Specialist, Global Clinical Supplies, will report to the Associate Director, Planning and Scheduling and their primary purpose is to coordinate packaging projects for clinical supplies executed by MSD or by a contract manufacturer. The person in this role will provide support on assigned projects from setup, coordination/monitoring of all activities for the assigned projects until completion across the different work centres of the supply chain (label design/printing, packaging and quality control).
Provides input and partners with other work centers to develop the packaging/labeling strategy for the individual clinical products.
Monitors the adherence to project schedules and documents progress in respective databases.
Assists the work centers (Global Project Management, Packaging, Label Operations, Quality disposition group) for issue resolution as needed.
Collaborates with global master planning and project management (demand and supply project managers) to establish priorities across different projects.
Negotiates timelines with contract manufacturers and requests/reviews quotes.
Orders multi‐language booklet labels from third party suppliers.
Generates Master Data (Material Master, Bill of Material, Recipe).
Generates project specific master documents (e.g. Batch Record).
Generates and releases process/print orders for production.
Works out proposals for continuous optimization of processes & procedures (SOPs) concerning clinical supply planning and packaging operations.
Main contact for the MSD Clinical Supplies Demand Manager and the contract manufacturer.
Good Manufacturing Practices and Compliance in general:
Develop, implement, and continuously improve processes and associated SOPs based on International Regulatory Standards, company Quality Guidelines and GMP regulations
Follow workflows and procedures according to current SOPs
Respect MSD policies concerning safety, health and environmental protection, finance, and quality
Is in permanent intensive contact with representatives of GCS Planning Organizations and participates in Clinical Supply Chain project teams.
Have contacts to third party packaging companies.
Higher degree (BSc, MSc) Engineering, Supply Chain, or another relevant Live Science discipline.
Familiarity with GMP requirements, quality procedures and SOP execution
At least 5 years of industry experience in a pharmaceutical, biotechnology or medical devices environment
Hands‐on experience in a clinical supply related area within the following areas: Planning, Scheduling, coordination, artwork and /or label translation
Proven project management skills
Direct work experience with SAP is a plus
Flexible and team‐ oriented
Diligent and quality‐ oriented
Structured and proactive working attitude
Proven ability to organize and manage multiple tasks at one time and meet deadline
German and English (verbal and written) at professional working level required
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.