Biochemist I/II - Recombinant Protein Manufacturing

Essential Functions

• Prepare various buffers for experiments, including cell culture media.
• Perform transformation and culture of bacterial cells (1-50 liters).
• Process the culture supernatant/cell pellet/inclusion body, followed by extensive processing or diafiltration to extract or refold raw protein bulk.
• Perform purifying recombinant protein by means of affinity tag.
• Perform technical training for MFG procedures.
• Support bottling and FGI lyophilization.
• Support activities related to audit readiness, CAPA and NC investigation.
• Monitor processing by SDS-PAGE for varied protein production stages.
• Perform bulk processing (concentration, dilution, buffer change), purity analysis and endotoxin removal.
• Support inventory management of raw material and plasmid constructs for protein production.
• Assist in transferring products across different departments for QC or other inventory-related activities.
• Maintain batch records and other documentations essential to compliance with ISO13485:2016.
• Maintain laboratory equipment and manage supplies.

Minimum Qualifications

• Bachelor's degree in Life Science or related area.
• 6-months of hands-on experience with bacterial and/or mammalian cell culture.

Preferred Qualifications

• Bachelor's Degree in Life Science or related area with at least 1 year of working experience in related biotech protein or antibody product manufacturing.
• Extensive experience in suspended E. coli culture.
• Experienced in purification and formulation of recombinant protein or antibody under ISO/GMP environment.
• Capable of working cross-functionally with other departments and coordinating projects internally and externally.
• Demonstrated ability to be detail-oriented, organized and work well in small work groups.
• Able to perform basic computer operations such as MS Office and Outlook and other computer-based software.

Work Environment & Physical Demands

Lab environment with occasional data entry on a computer and occasional exposure to a warehouse environment. Regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. Frequently required to stand, talk and hear.