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Scientist II, Upstream Process Development

Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio .

We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.

Vir Bio is seeking an experienced scientist or engineer to develop antibody cell culture processes used for cGMP production of Vir's pipeline of therapeutic antibodies. This position will work primarily with third parties (e.g., CDMOs and suppliers) for early and/or late stage clinical development programs as well as design, execute, and analyze cell culture process development experiments in house. As a member of the Vir Biotechnology Process Development team, they will work with our partners to support clinical cell culture process development and late phase process characterization. In this role, they will design, optimize and analyze complex experiments in a team setting and work towards scalable cell culture processes for the production of recombinant antibodies around the world. In addition, they will represent work at functional area meetings and provide cross-functional support for purification development, analytical development, formulation and drug product teams, process analytics, manufacturing sciences, and other CMC functions.

RESPONSIBILITIES AND LEARNING OPPORTUNTIES:

    • Develop scalable processes such as mammalian cell culture and harvest processes for upstream cell culture development for and with our CDMO partners
    • Designs scientifically rigorous experiments using statistical DoE where applicable and execution of experiments, analyze and interpret data to further craft next studies.
    • Design and implement early-stage process development and late-stage upstream process characterization and process validation studies
    • Provide technical oversight for outsourced process development and cGMP production with CDMO's
    • Participate in process tech transfers and coordination of manufacturing internal and external interfaces for reporting and solving of cell culture processes.
    • Author technical process development reports, process descriptions, and any other relevant process documentation (e.g., SOPs, protocols, etc.)
    • Reviews process descriptions and batch records during cGMP operations and tech transfer.
    • Perform On-site lab work and coverage of weekend work to support experiments (estimated ~8 hours/month)
    • Lead and implement experiments in the design, development, optimization and scale-up of protein production processes in suspension cell culture systems (shake flasks, AMBR250, bench scale bioreactors)
    • Prepare documents/presentations/materials for meetings, conferences and/or presentations



QUALIFICATIONS AND EXPERIENCE:

    • B.S./M.S. or Ph.D. in chemical engineering, biochemistry or related fields
    • 8 + years (B.S.), 6+ years (M.S.) or 3 + years (Ph.D.) of experience in protein upstream process development.
    • Experience operating in early stage clinical to commercial environments.
    • Proven understanding of cGMP antibody process development and production using CHO host cell expression systems.
    • Hands-on experience with mammalian cell culture, aseptic techniques, understanding of biochemical engineering concepts, and biochemical pathways.
    • Experience in developing and improving scalable fed-batch, transfection, and perfusion upstream processes in PD setting.
    • Familiar with Bioreactor Scale-up concepts and have a proven track record for scaling-up processes to disposable/stainless bioreactors.
    • Ability to use Design of Experiments in JMP, Design Expert, or other for statistical experimental design, and data analysis.
    • Experience with contract development and manufacturing preferred
    • Knowledge of statistical process control, QbD, and PAT concepts preferred
    • Ability to travel approximately 15%.



#LI -Onsite SF

Vir's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all lab essential personnel!

Vir is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.

Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

Scientist II, Upstream Process Development

San Francisco, CA
Full Time

Published on 08/01/2022

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