Packaging Contractor

Packaging Contractor – JD (20 hrs/ wk)

• Drive the primary, and/or secondary packaging, and release of clinical supplies at external CDMO’s for assigned projects, ensuring full adherence to project timelines.
• Ensure that the packaging configurations and materials ordered align with available stability data and protocols to comply with use dating assigned for various CTM.
• Review and approve specifications, master production instructions, executed batch records and other relevant documents from the vendors/ CDMOs for packaged product.
• Support the approval of label text and maintaining communication between the Technical Operations and Clinical Operations for relevant data.
• Support packaging operations and represent the clinical supplies function on various internal and external operational teams.
• Participating and presenting as needed for various co-ordination team meetings and other forums.
• Progress shipments of clinical trial materials along the supply chain to ensure product availability to the depot for clinical distribution.
• Scheduling and approval of shipments and vendors and material tracking from manufacturing sites to receipt at the depots.
• Create, lead, and manage batch genealogy tables from starting materials to labeled products to ensure traceability for each clinical lot.
• Calculation of unit costs by reviewing various contracts and invoices for each released lot of material to ensure compliance with customs and cross-border commerce requirements.
• Create packaging plans based on timelines and ensure contracts are in place to execute these plans.
• Assist in risk identification and mitigation for gaps regarding clinical materials, in cases of material shortages due to expiration and consumption.
• RFPs, RFQs, POs and contract management for packaging, labeling and distribution activities at various vendors and CDMOs. Approval of various invoices related to packaging and labeling ensuring accuracy and timeliness of the charges.
• Serve as the packaging SME in regulatory reviews of INDs/ IMPDs and other filings.
• Work closely with Quality, Regulatory, Clinical Operations, Finance, Purchasing and other departments to support on-going clinical supplies manufacture and shipments.
• Utilize appropriate software and IT systems to manage the execution of key project activities.

We’d be looking at a candidate profile with a BS/ MS in a scientific discipline with 7–10-year relevant experience in pharma packaging and labeling and drug product development.

Remote with some travel.

Pay ranges between 60-75/hr based on experience