Scientist II, Cell Culture
Fremont, CA · Full time
The Scientist II, Cell Culture will actively contribute to the development and technology transfer of projects at the Bionova Scientific West Warren site. The position performs professional planning, coordination, analysis and reporting of various project work according to Bionova Scientific guidelines and project management strategies. The role will frequently provide hands-on execution of complex shake flask and bioreactor experiments in a team setting. The position will train, supervise, and mentor technical staff with opportunities for growth into management.
The role will support and oversee assigned portions of GMP readiness activities. The scope of responsibilities may include but are not limited to Document writing (SOPs, Equipment URSs, etc.), equipment validation execution support and single-use assembly design.
Duties & Responsibilities
Hands-on execution and troubleshooting of cell culture activities using shake flasks, AMBR 15, AMBR 250, and bioreactors from 2 L to 2000 L scale.
Oversee junior scientists in equipment troubleshooting, upstream process development, characterization studies, pilot scale material generation, non-GMP tox material generation and GMP upstream manufacturing activities.
Write and review experimental plans, protocols, production batch records, training materials, and technical reports.
Collaborate with clients to plan and execute various programs and ensure the successful development of lead biotherapeutics.
Oversee technology transfer activities at the client site or to Bionova Scientific’s GMP facility.
Conduct root-cause investigations and identify solutions to resolve cell culture development and manufacturing related issues.
Bachelor's degree in Engineering, Life Sciences, or related discipline with 4+ years of relevant experience, or combination of experience and relevant advanced degree, focused on cell culture preferably in biopharma process development or manufacturing role.
GMP experience is a plus.
Experience with automation and high throughput technologies is a plus.
In-depth knowledge of mammalian cell culture performance is required.
Strong analytical skills and attention to detail.
Experience in developing process development, process characterization and/or tech. transfer processes.
Flexible mindset for a dynamic environment.
Strong project management capabilities.
Ability to independently evaluate technical situations and propose potential solutions.
Ability to communicate clearly and professionally in writing and verbally.
Basic understanding of data and statistical analysis of results.
Must be able to work independently as well as work with a diverse team.
Ability to prioritize assignments and to manage multiple projects simultaneously.
Capable of independent and rapid decision making based on data, scientific knowledge, and sound judgement
Must have the ability to work efficiently in a fast-paced environment.
Flexibility with work hours to meet business needs, including weekends and holidays, as needed.
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.
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.