Biochemist I – GMP

Revvity•San Diego, CA

2d•$26 - $29•Onsite

About The Position

The Biochemist I – GMP position will be responsible for the different stages of manufacturing various BioLegend’s regulated product produced in our US FDA registered cGMP manufacturing facility. This role will be responsible for formulating and vialing, completing batch records, putting away finished good inventory (FGI), data entry, equipment maintenance and supply inspections & storage. Other responsibilities include buffer preparation and inspection of incoming buffers into the GMP suite, as well as material preparation for Lyophilization and post lyophilization processes. This role will prepare product/project related documentation and maintain the device history records for all the regulated products and will work closely with product development on new products in order to establish a smooth transition into manufacturing. Applicants must be currently authorized to work in the United States on a full-time basis for any employer. The Biochemist I – GMP will work independently and as a team player. The ideal candidate will be organized and detail oriented, have strong communication skills, and is able to work in a very fast paced environment.

Requirements

Bachelor’s degree with 1-year biotechnology industry experience.
1 year of working experience with Good Documentation Practices (GDP)

Nice To Haves

Bachelor’s degree in: Biology, Biochemistry, Chemistry, or other related areas
Working experience in the Biotechnology industry with quality system knowledge including ISO 13485 or cGMP regulation is a plus.
1 year of experience in a laboratory and/or biotech manufacturing environment, performing filling, bottling, and packaging.
Advanced pipetting skill is highly preferred.
Familiarity with raw material supply receiving and inspection processes.
Excellent verbal and written communication skills
Demonstrated knowledge of aseptic techniques in biosafety cabinet
Demonstrated ability to work well in small groups and adhere to timelines.
Excellent attention to detail and organizational skills

Responsibilities

Prepare various buffers for manufacturing activities.
Perform incoming inspection of raw materials.
Perform formulation and vialing of regulated products, which includes filling, capping, and labeling.
Assist in troubleshooting the manufacturing process.
Maintain batch records and other documentations in compliance with ISO13485:2016 and cGMP.
Maintain/troubleshoot laboratory equipment and manage supplies.
Perform data entry tasks, including processing production orders.
Work as a team to advance multiple projects simultaneously
Other projects or responsibilities may be required.