Commercial Packaging and Clinical Trial Supplies Manager (6441 - KFR)
Commercial Packaging and Clinical Trial Supplies Manager
For our client, an innovative and dynamic bio-pharmaceutical company covering multiple therapeutic areas, committed to delivering products on the market over the next 5 years, we are looking for a Commercial Packaging and Clinical Trial Supplies Manager for a 12-month contract (with possibility of extension) based in Basel area, Switzerland.
Main Responsibilities:
Clinical Trial Set up
1. Ensure timely delivery of clinical trial supplies for assigned projects based on input from CMC and CTT.
2. Attend study kick off meetings and elaborate the overall supply plan.
3. Develop the most suitable packaging solution.
4. Consider supply risk management in study planning.
5. Coordinate activities for completion of primary and secondary packaging.
6. Develop compliant label text and print booklets / labels.
7. Generate a material list taking into consideration the pack types and blinded status of the study.
8. 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
1. Develop a distribution plan with the external service utilising the best most efficient distribution network in terms of timelines, quality and cost.
2. Select the most appropriate carrier option for the clinical trial supplies.
3. Ensure all relevant distribution documentation is completed in advance including transport conditions and available to the CMO.
4. Complete and review Import licenses, proforma invoices where appropriate.
5. Provide the study team CROs responsible for importation, quantities required for specific countries.
Clinical Trial returns / destruction and close out
1. Complete returns process with the external service provider.
2. Provide complete details to study team.
3. Complete destruction at the earliest available time.
4. Receive Certificates of destruction.
Documentation
1. Set up binder / TMF and eTMF for each clinical study.
2. Maintain binder throughout duration of study.
3. Close binder and provide to relevant clinical team for long term storage.
Communication
1. Ensure excellent communication between all stakeholders.
2. Present the overall clinical supply program to the CMC team.
3. Communicate and escalate any challenges or potential supply issues to team leader of CPCTS and where appropriate CMC/CTT.
Commercial packaging
1. Part of Commercial image definition team, with representatives from CMC, life cycle, DRA, QA TRA and marketing.
2. Work to define the primary and secondary packaging requirement for the commercialisation of the product.
3. Single point of contact of packaging suppliers, contract packagers, and packaging test laboratories.
4. Assess packaging technical changes and impact on overall product quality.
5. Create a registration packaging plan that includes all relevant activities and is in collaboration with CMC Team.
Artwork
1. Provide mock ups to DRA for submission.
2. Provide the technical approval of the final artwork.
3. Provide fully approved artworks to the CMO for printing.
Qualifications and Experience:
1. Relevant working/residency permit or Swiss/EU-Citizenship required
2. University degree or equivalent working experience in life sciences.
3. At least 3 or more years’ experience in the field of Commercial packaging or Clinical Trial Supply.
4. Knowledge of the relevant international GMP, GDP, GCP regulations.
Seniority level
Associate
Employment type
Temporary
Job function
Project Management, Strategy/Planning, and Supply Chain
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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