Manufacturing Research Associate

5 days ago

San Diego, California, United States Excellos, Incorporated Full time
Job Summary

This position is located at our Downtown San Diego facility and requires on-site presence. The Manufacturing Research Associate performs routine isolation and characterization of cells according to established procedures and supports product development efforts.

Key Responsibilities
  • Perform isolation, characterization, and cryopreservation of cell products according to established procedures.
  • Conduct laboratory testing utilizing various analytical techniques, including flow cytometry, cell counting, and other cell-based assays to support RUO or GMP manufacturing.
  • Assist in the validation of new manufacturing procedures and equipment.
  • Support the transfer of new processes/products and testing methods into Excellos manufacturing and quality control facilities, working directly with clients and/or Excellos PD/AD teams.
  • Assist in drafting SOPs, BPRs, manufacturing records, and test methods to support technology transfer and ongoing development of manufacturing projects.
  • Analyze and perform calculations to assess results of manufacturing processes and test methods.
  • Perform procedures and maintain accurate documentation in compliance with Excellos quality plan and Good Laboratory Practices.
  • Maintain comprehensive manufacturing and testing records.
  • Handle inventory and prepare cellular products and relevant documentation for shipment to customers.
  • Perform routine maintenance of lab equipment and environment.
  • Maintain supply inventory levels, order laboratory reagents and supplies as needed.
  • Adhere to production schedules to ensure on-time production logistics and fulfillment of client requests.
  • Participate in departmental and organizational projects and provide routine updates to cross-functional stakeholders.
  • Assist in investigations of departmental deviations, OOS, and customer complaints.
Working Environment

This role primarily involves working in an office/business environment with normal laboratory conditions and biohazard precautions. May be exposed to blood or bodily fluids that may be capable of transmitting diseases and chemicals that may be hazardous.

Physical Requirements

This position requires the ability to stand or sit for long periods, work on a computer for 4-8 hours a day, communicate clearly, and may require lifting up to 40 pounds.

Equipment Used

This role involves the use of general laboratory equipment, including centrifuges, heat sealers, sterile docking devices, refrigerators/freezers, sterile hoods, cell counters, cell isolation and analysis systems, and FACs analyzers, as well as Laboratory Information Management Systems software.

Qualifications

Education: Bachelor's degree in a science-related field. Experience: Minimum of 2 years related lab experience. Strong attention to detail and ability to follow written procedures. Laboratory experience with working knowledge of basic lab procedures. Previous experience with sterile technique and human biospecimens. Previous cGMP experience preferred. Skills: Keen attention to detail, well-organized, self-motivated, flexible, and capable of independent work with changing priorities. Ability to perform advanced troubleshooting of scientifically technical problems. Ability to adapt to new technologies. Ability to work under minimal supervision. Interpersonal skills to establish and maintain professional relationships. Ability to work collaboratively as a member of a team and to communicate effectively within an interdisciplinary environment. Ability to work well under pressure and meet critical timelines. Ability to work, learn, adapt, and execute in a fast-paced commercial environment.

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