Commercial Packaging and Clinical Trial Supplies Manager (5868)

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Our client, an innovative and dynamic biopharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed to delivering products on the market over the next 5 years, is looking for a Commercial Packaging and Clinical Trial Supply Manager for a 12-month contract role with the possibility for a permanent position based in the Basel area.

Commercial Packaging and Clinical Trial Supply Manager – 5868 LBD

Main Responsibilities

Clinical Trial Set up

• Ensure timely delivery of clinical trial supplies for assigned projects based on input from CMC and CTT
• Attend study kick off meetings and elaborate the overall supply plan
• Develop the most suitable packaging solution
• Consider supply risk management in study planning
• Coordinate activities for completion of primary and secondary packaging
• Develop compliant label text and print booklets / labels
• Generate a material list taking into consideration the pack types and blinded status of the study
• Participate in the IRT setup, complete CTS specific documentation, set up should take into
• consideration study specific requirements, clinical trial supply expiry
• Clinical Trial Distribution
• Develop a distribution plan with the external service utilising the best most efficient distribution network in terms of timelines, quality and cost
• Select the most appropriate carrier option for the clinical trial supplies
• Ensure all relevant distribution documentation is completed in advance including transport conditions and available to the CMO
• Complete and review Import licenses, proforma invoices where appropriate
• Provide the study team CROs responsible for importation, quantities required for specific countries
• Clinical Trial returns/ destruction and close out
• Complete returns process with the external service provider
• Provide complete details to study team
• Complete destruction at the earliest available time
• Receive Certificates of destruction Documentation
• Set up binder / TMF and eTMF for each clinical study
• Present the overall clinical supply program to the CMC team

Commercial packaging

• Part of Commercial image definition team, with representatives from CMC, life cycle, DRA, QA TRA and marketing
• Work to define the primary and secondary packaging requirement for the commercialisation of the product
• Single point of contact of packaging suppliers, contract packagers, and packaging test laboratories
• Assess packaging technical changes and impact on overall product quality
• Create a registration packaging plan that includes all relevant activities and is in collaboration with CM team

Artwork

• Provide mock ups to DRA for submission
• Provide the technical approval of the final artwork.
• Provide fully approved artworks to the CMO for printing
• Serialisation
• Application manager responsibility

Qualifications And Experience

• Swiss working/residency permit and/or Swiss/EU-Citizenship required;
• At least 5 years relevant experience in the Pharmaceutical industry
• Working knowledge of commercial packaging activities, validation and artwork creation
• Experience of working with and overseeing CMOs
• Understanding of GMP packaging regulations and requirements
• knowledge of the relevant international GMP,GDP, GCP regulations
• Serialization experience would be beneficial
• Good project management skills, ability to handle multiple task and projects concurrently and a track record of delivering projects on time, to completion
• Excellent team working skills within cross functional groups
• Fluent in English (Written and Spoken)