What are the responsibilities and job description for the Supply Chain Specialist position at Actalent?
As part of the External Manufacturing and Supply Chain team within Technical Operations, this individual will support to manage external manufacturing and testing services partners. This individual should have knowledge of traditional biologics manufacturing processes and production in cGMP environment. This includes cell banking, drug substance, drug product manufacturing, Quality control testing and release. Any experience in Gene and Cell Therapy would be a plus but not necessary. They should also understand working in an FDA regulated environment and producing materials under cGMP’s for human use.
Role Responsibilities:
• Support search and evaluation of external partners and CDMOs for sourcing of critical raw materials.
• Maintain external CDMO/CRO partners update tracker related to GMP manufacturing planning, and execution.
• Coordinate and support review of CDMO batch records, technical reports to ensure cGMP quality standards are met to facilitate product disposition.
• Collaborate with internal analytical development and CDMO Quality Control to ensure that all release, characterization, and stability data set is up to date.
• Support closure of Quality events (deviations, investigations, Vendor Change Notices, etc.) within internal Quality Management System.
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
