Biochemist I - GMP Manufacturing

Revvity•San Diego, CA

1d•$22 - $29•Onsite

About The Position

This Biochemist supports multiple steps in the manufacturing of BioLegend’s regulated products within our FDA-registered cGMP facility. Responsibilities include formulation, filling, capping, labeling, completing batch records, managing finished goods inventory (FGI), data entry, equipment maintenance, and organizing and inspecting supplies. You will also support purification and conjugation of monoclonal antibodies using an AKTA system, as well as buffer preparation and inspection of materials entering the GMP suite. In addition, this role includes assisting with product documentation, maintaining device history records, and working with Product Development to help transition new products into manufacturing. The ideal candidate is a dependable team player who is organized, detail-oriented, and comfortable working in a fast-paced environment. Strong communication skills and the ability to work independently while meeting deadlines are important for success in this role.

Requirements

Bachelor's degree with some industry experience.

Nice To Haves

Bachelor's degree with a minimum of 1-year Lab experience.

Responsibilities

Prepare various buffers for manufacturing activities.
Perform incoming inspection of raw materials.
Perform formulation and vialing of the regulated products.
Assist in troubleshooting the manufacturing process.
Maintain batch records and other documentations that are essential to be in compliance with ISO13485:2016 and cGMP.
Maintain/troubleshoot laboratory equipment and manage supplies.
Process purification or conjugation orders as needed through the AKTA system.
Perform dialysis, centrifugation, and column chromatography.
Conduct Endotoxin tests.
Advance multiple projects simultaneously and work in a team environment.
Other projects or responsibilities as may be required.