Business Description
The Biologics Clinical Operations & External Partnerships (BCO & EP) department is responsible for the production of Biologics Drug Substance (DS) clinical supplies at 3rd party contract manufacturing organizations (CMO’s), Drug Product/Drug Substance (DPDS) internal sites, and Innovative Medicine Supply Chain (IMSC) internal sites. The Malvern Clinical Operations (MCO) team is responsible for manufacturing the Biologics DS (drug substance) clinical supplies at the Malvern manufacturing site. The NPI Coordinator position in Malvern is responsible for delivery of the NPI process to the manufacturing site for New Molecular Entities (NME’s), resupplies and phase changes of API clinical materials per Chemistry, Manufacturing, & Controls (CMC) timelines.
Objectives & Responsibility
New Product Introduction (NPI) Tech Transfers
Site Manufacturing Management and Relationships
Qualifications and Skills Required:
Qualifications and Skills Preferred:
General
Compensation:
$30-40/hr
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
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