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.
We are the people who give possibilities purposeBD 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 DescriptionJob ResponsibilitiesTissue 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.
Why Join Us?To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visithttps://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
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Primary Work LocationUSA PR Cayey - Vicks Drive (BDB)
Additional LocationsWork ShiftPR 700am-330pm M-F (United States of America)
