As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.
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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.
Job Description
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…