Clinical distribution and Logistics manager

Peptomyc is looking for a responsible person with great communication abilities, sense of organization and enthusiasm to join its dynamic team and take care of logistics and manufacturing documentation.

Full-time and immediate incorporation.

 

Background and skills:

  • Excellent spoken and written English and Spanish levels
  • Excellent communication skills
  • Very well organized
  • Enjoy working in a fast-paced environment
  • Experience in R&D start up and/or pharma logistics is a plus
  • Bachelor’s degree in Biomedicine/Biotechnology/Pharmacy or related field would be preferred

 

Tasks:

Shipments of Investigational Medicinal Product (IMP), Drug Substance (DS) and Drug Product (DP), in coordination with the CSO:

  • Coordinate with the DS and DP manufacturers for the release and reception of each DS and DP batch and obtain of the required documentation
  • Coordinate with logistics provider to organize international shipments of DS and DP and prepare the required documentation

Production and shipment of IMP labels:

  • Coordinate with the label manufacturer for the production of IMP primary labels (vial labels) and secondary labels (carton labels)
  • Coordinate with the logistics provider to organize international shipments of labels and prepare the required documentation

Clinical Trial logistics, in coordination with the Clinical Project Leader, CMO and the clinical CRO:

  • Participate in the writing/amendments of the Clinical Distribution Manual and Pharmacy Manual
  • Organize the packaging and secondary labelling activities for each IMP batch
  • Liaise with CRO to communicate with the site pharmacies
  • Closely follow up the vial use at clinical sites and coordinate the shipment of IMP with the logistics provider by preparing the required documentation
  • Control of central IMP stock to prevent any IMP supply shortage to clinical site pharmacies
  • Identify temperature deviations and prepare the documentation to release the IMP from quarantine
  • Organize the retrieval of unused IMP from clinical site pharmacie

Administration, in coordination with CFO and external support:

  • Revise vendor budgets/offers
  • Generate purchase authorizations (purchase orders)
  • Prepare customs invoices and revise invoices from vendors
  • Provide information for import tax payment and VAT filing

Ensuring compliance with CMC SOPs:

  • Review and file analytical and quality documents for the DS and DP batches
  • Fill in and file internal documents related to batch releases and quality as per CMC and Clinical SOPs
  • Ensuring up to date documentation according to quality manual

 

If you are interested in this offer, please send your CV to info@peptomyc.com