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Associate Scientist I, Process Development & Manufacturing

Fremont, CA • Full Time

Job Description
The Associate Scientist I will actively contribute to the scientific development and technology transfer of projects at the Bionova Scientific West Warren site. As part of the group, you will have opportunities to work on and take ownership of a wide-ranging set of projects learning aspects of process development and manufacturing implementation including upstream cell culture fermentation and downstream purification. The role will frequently provide hands-on execution of complex processes in lab and in a GMP manufacturing environment. This role will also support troubleshooting and investigations, facility buildout, and tech transfer of processes in the development lab and GMP manufacturing facility.

The role requires planning, detailed study execution, analysis, documentation and reporting of various project work according to Bionova Scientific guidelines and project management strategies.

Duties & Responsibilities

  • Rotate between upstream cell culture and downstream purification process to support lab experiments and manufacturing activities. Candidate will have the opportunity to focus more on one area either upstream or downstream to build greater proficiency.
  • Upstream cell culture work will involve:
  • Hands-on execution and troubleshooting of cell culture fermentation in shake flasks and bioreactors up to 2000 L
  • Media preparation, bioreactor assembly, and harvest
  • Monitoring and daily sampling of fermentation process
  • Collecting and analyzing data, troubleshooting, and present summary of findings
  • Downstream purification work will involve:
  • Hands-on execution of protein purification using various chromatography and protein analytical techniques.
  • Buffer preparation and protein concentration, quantification, and formulation
  • Collecting and analyzing data, troubleshooting, and present summary of findings
  • Author/review technical documents such as process development reports, tech transfer protocols and reports, experimental plans, production batch records, training & manufacturing SOPs, and regulatory filing documents per project needs.

Requirements

  • BS or higher in Biochemistry, Biology, Chemistry, Chemical Engineering, or related discipline with 1+ year of lab experience, or advanced degree.
  • General understanding of biopharma, cell culture and purification concepts
  • Experience working in a lab with aseptic techniques and detailed-oriented
  • Ability to communicate clearly and summarize and present results in both written format and group presentations.
  • Must have the ability to work both independently and in a team setting within a fast-paced environment
  • Flexibility with work hours to meet business needs, including weekends and holidays, as needed.

Eligibility Requirements

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background.
  • Must be willing to take a drug test and post-offer physical (if required).
  • Must be 18 years of age or older.

Ready to Apply?
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Bionova Scientific is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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