bakersfield | Process Development and TT Associate II in San Diego, CA

Process Development and TT Associate II

  • Ajinomoto Bio-Pharma Services
  • 9944 Barnes Canyon Rd
  • San Diego, CA 92121
  • Full-Time
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Let?s Make A Difference!





At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.





Every team member at Ajinomoto Bio-Pharma Services, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry?s top leaders for large molecule manufacturing andaseptic drug product fill in vials and syringes.





We believe our people are the greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come. If you enjoy working in a fast-paced, inspiring, and values-driven culture, Ajinomoto Bio-Pharma Services is the place for you.





Together, Let?s Make A Difference.





Ajinomoto Bio-Pharma Services is currently seeking a Process Development and TT Associate II to support functions related to the development, implementation, and tech transfer of Antibody Drug Conjugate (ADC) conjugation, purification, and pre-formulation processes.





Responsibilities:




  • Develop scalable, robust conjugation processes by conjugating, purifying, and analyzing antibody-drug conjugates using representative scale down models and associated analytical methodologies (e.g. HPLC and UV-Vis spectroscopy).

  • Support technical transfer, scale-up, manufacturing, and regulatory activities through collaboration with Quality, Manufacturing, Analytical, and Process Development groups.

  • Evaluate, optimize, and implement novel conjugation techniques and process analytical technologies (PAT).

  • Execute process characterization studies for ADCs using design of experiments (DOE) and quality by design (QbD) approaches.

  • Help prepare technical papers, reports, and presentations.

  • Prepare components, buffers, and other solutions as needed.

  • Maintain the highest of professional standards for laboratory safety and record keeping.

  • Responsible for routine maintenance of laboratory equipment, inventory management, and Purchase Order Requests (PORs).

  • May cross train on various tasks including downstream cGMP manufacturing as needed to support overall success of the ADC group.





Requirements:




  • High School Diploma required. Bachelor's Degree in Life Sciences discipline strongly preferred.

  • Minimum of two to four (2-4) years of relevant experience in antibody bioconjugation, ADC development, or related research area.

  • Knowledge of bioconjugation chemistry and analysis.

  • Hands-on wet lab method experience within a biopharmaceutical or biotech organization preferred.

  • Basic experience and/or familiarity with protein characterization and purification techniques (HPLC, UVvis, TFF, ion-exchange chromatography).

  • Familiarity with cGMP, aseptic techniques, troubleshooting, machine operations, and data entry.

  • Proficiency with Microsoft Office applications; Unicorn software or Chromeleon experience is a plus.

  • Familiarity with process development, design of experiments (DOE), and quality by design (QbD), is a plus.

  • Strong attention to detail with effective written and verbal communication skills.

  • Demonstrated ability to work independently, within prescribed guidelines, and as a part of a team.

  • Ability to multi-task and maintain detailed experimental records.







If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the \"Careers\" section. Please be sure to note where you saw our ad posting.





Successful candidate must pass a background check and drug screen as a condition of employment.





We are an EOE dedicated to a diverse work force and Drug Free work environment.



Qualified M/F/D/V candidates are encouraged to apply.



Associated topics: hematopathology, lab, microbiology, mls, mlt, scientist, sterile processing technician, surgical technologist, technician i, technician lab


* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.