Biochemist II

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

• →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.

• 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.

• 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.

• 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.

• 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 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.