Scientist I/II, Purification
Fremont, CA · Full time
The Scientist I/II, Purification will actively contribute to the development and technology transfer of projects at the Bionova Scientific West Warren site. As part of the Purification/Manufacturing group, you will have opportunities to work on and take ownership of a wide-ranging set of projects from process development, to troubleshooting and investigations, system and workflow implementation, facility buildout, and tech transfers of processes into the development space as well as the GMP manufacturing facility. 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 experiments in a team setting. The position will train, supervise, and mentor technical staff with opportunities for growth into management.
The role will support 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
Mentor and train junior staff members by providing guidance on scientific principles and their practical applications to protein purification
Oversee junior scientists in equipment troubleshooting, downstream process development, characterization studies, pilot scale material generation, non-GMP tox material generation and GMP downstream manufacturing activities.
Author/review/approve technical documents such as process development reports, tech transfer protocols and reports, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.
Collaborate with clients to plan and execute development, optimization, and validation of purification processes as well as process transfers to and from client sites.
Oversee technology transfer activities at the client site or to Bionova Scientific’s GMP facility.
Support and lead meetings with clients to move projects forward and/or triage issues.
Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.
Evaluate new technologies and innovations to improve operational efficiency or expand purification capabilities
Interpret data from studies and make recommendations for best courses of action as they pertain to drug and process development
Troubleshoot equipment and testing to identify root causes of issues
Present during inspections from regulatory agencies and client audits
BS, MS, or PhD in Engineering, Life Sciences, or related discipline with 5+ years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma process development or manufacturing role.
In-depth understanding of protein chemistry and industry-standard purification processes (affinity, IEX, SEC, viral inactivation and filtration, depth filtration, TFF, UFDF, etc) and equipment (GE AKTAs, disposables)
Hands-on experience in running, developing, and validating processes
Experience in process development, process characterization and/or tech. transfer processes.
Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing
Experience with process monitoring software and equipment software (UNICORN, Pi Historian)
Creative thinker that can identify better and more efficient methods to address issues and gaps
Demonstrate ability to work independently and on cross-functional teams
Strong analytical skills and attention to detail.
Effective verbal and written communication skills
Flexible mindset for a dynamic environment.
Ability to independently evaluate technical situations and propose potential solutions.
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.
Management experience is a plus
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.