Manufacturing Associate - ELISA
Inspiring advances in bioprocessing, Repligen is a leader in bioprocess filtration, pre-packed chromatography and Protein A ligands development. Propelled by a culture of innovation and collaboration, and with a focus on cost and process efficiencies, our people and our technologies help meet critical bioproduction demands worldwide. Named one of the fastest growing biotech companies in the USA, Repligen is headquartered in Waltham, Massachusetts with major manufacturing sites in Massachusetts, California, Sweden, and Germany.
Repligen offers the broadest range of hollow fiber and flat sheet filtration technologies for cell culture and purification, featuring XCell® ATF Systems, Spectrum® KrosFlo TFF Filters and Systems and TangenX® Flat Sheet TFF Cassettes. As the expert in pre-packed chromatography technology, Repligen offers OPUS® Pre-packed Columns with unparalleled flexibility and scalability from bench- to production-scale. Since 1985, Protein A affinity ligands manufactured by Repligen have been routinely used to purify most of the world’s monoclonal antibodies.
The ELISA Manufacturing Associate will assist in the ELISA Lab Manufacturing group by building the Kit reagents for ELISA Kit Inventory. This person will focus on training and working with the Manufacturing Associate ll and the ELISA Manager.
- Train in all aspects of Repligen ELISA Kit Manufacturing
- Able to use Pipettes and have ELISA testing experience
- Responsible for ensuring all ELISA Manufacturing operations are carried out in accordance with the Repligen ISO 9001 Quality Management system
- Manufacture all ELISA Reagents : perform dispensing, capping and labeling operations per approved Batch records
- Manufacture ELISA Plates: perform coating, blocking ,washing and packaging of plates per approved Batch records
- Package Kits for Inventory
- Interact with Materials Management to purchase of Raw Materials required.
- Ensure the timely completion of all Paperwork and work sheets, using ERP and EDMS
- Maintain an appropriate level of housekeeping and safety within the ELISA Lab
- Requires an AS/BS or equivalent with 2 + years of relevant experience in document controlled manufacturing.
- Skilled in the manufacture and testing of ELISA products is preferred.
- Previous experience in QC or Analytical Development is desirable
- Experience in GMP or ISO9001 manufacturing environment is preferred