Biochemist II

Job Responsibilities

Tissue Culture (TC) Area

• Create, maintain, and test Master and Working Cell Banks of antibody-producing hybridomas.
• Conduct in-process testing for viability, secretion, and sterility.
• Process cell culture supernatant to remove debris and concentrate product prior to purification.
• Monitor the cell culture process using biochemical and immunological procedures.
• Formulate purified materials according to finished-goods specifications and dilution batch records.

Purification Area

• Perform incoming testing of culture media, ascites fluids, and other materials requiring evaluation using available purification techniques.
• Test and purify monoclonal antibodies from serum/ascites fluid and tissue culture supernatant using appropriate serum fractionation and/or column chromatography techniques.
• Formulate monoclonal antibody reagents according to finished-goods specifications and dilution batch records.
• Perform resin retesting and reclamation processes.

Conjugation Area

• Conjugate monoclonal antibodies from purified materials using required fluorophores, dyes, or other molecules.
• Monitor the conjugation process at various stages to maximize product yield and quality.
• Formulate conjugates according to finished-goods specifications and dilution batch records.
• Prepare maleimide and raw materials based on production plan requirements.
• Maintain chromatography systems, including column packing, cleaning, and equilibration, and report equipment issues as needed.

General Responsibilities

• Perform required in-process testing.
• Complete material movement transactions in SAP and perform inventory control activities to maintain accuracy.
• Maintain detailed production records, logs, and documentation.
• Generate quality reports, including Out of Specification (OOS) and Deviation Reports.
• Initiate and participate in investigations according to established quality procedures and approved protocols.
• Perform equipment cleaning, inspection, calibration verification, maintenance, and troubleshooting.
• Participate in the development and revision of Standard Operating Procedures (SOPs).
• Support project-related activities as required.
• Follow all safety procedures and actively participate in Environmental Health & Safety (EH&S) programs.
• Identify and report hazardous conditions or unsafe work practices.
• Maintain compliance with applicable regulatory requirements and participate in required regulatory training.
• Participate in the Daily Management System, including shift start-up meetings and reporting appropriate metrics.
• Participate in Continuous Improvement initiatives.
• Recommend improvements to enhance product/process quality and availability, reduce costs, and increase production capability.
• Maintain good housekeeping practices.
• Participate in Knowledge Transfer activities as required.
• Perform other related duties and assignments as needed.

Education & Experience

• Bachelor's degree in a related scientific discipline, such as Chemistry, Biochemistry, Biology, Microbiology, or Engineering.
• Minimum of 1 year of experience in a laboratory, pharmaceutical, medical device, or biotechnology environment.
• An equivalent combination of relevant education and experience may be considered.

Knowledge & Skills

• Knowledge of methods used to create, maintain, and test Master and Working Cell Banks of antibody-producing hybridomas.
• Experience with laboratory equipment such as micropipettes and volumetric devices, microscopes, microplate readers, CO2 incubators, centrifuges, biosafety hoods, spectrophotometers.
• Knowledge of monoclonal antibody purification using serum fractionation and/or column chromatography techniques.
• Basic understanding of chemicals and kinetic reactions.
• Knowledge of FPLC, HPLC, UV monitors, electrophoresis, and size-exclusion columns preferred.
• Knowledge of reagent formulation.
• Knowledge of GMP, FDA, ISO, and OSHA requirements highly desirable.
• Knowledge of SAP highly desirable.
• Working knowledge of Microsoft Office and the Windows environment.
• Strong analytical thinking, problem-solving, communication, interpersonal, planning, and organizational skills.
• Ability to follow established policies and procedures.
• Fully bilingual in English and Spanish.
• Willingness to travel to the U.S. mainland and offshore locations.