THE OPPORTUNITY
Vir Bio seeks candidates who are highly self-motivated and can work in a collaborative fashion with other interdisciplinary team members in a fast-paced company that seeks to transform upstream bioprocessing. The Upstream Process Development team is responsible for the development and implementation of upstream processing methodologies on monoclonal antibodies that can be efficiently transferred to the cGMP Manufacturing Team and our CDMO partners. Additionally, the Upstream Process Development team supports other groups including Research and Development, Cell Line Development, Downstream Process Development, Manufacturing Science and Technology (MSAT), and External Manufacturing. The primary focus of this role is to contribute to the pilot lab build up for Vir’s monoclonal antibody portfolio, execute lab scale experiments to assess platform fit, develop phase appropriate upstream processes, and plan, execute, and summarize bench and pilot scale production batches. Additionally, within this role, the candidate will have the opportunity to follow the process through pilot downstream operations, assist with pilot scale buffer preparation, support tech transfer to cGMP facilities and support late phase process development and process characterization studies with Vir’s CDMO partners.
This role is located in San Francisco at our corporate office and there is a requirement to be onsite at least three days per week.
WHAT YOU'LL DO
- Develop scalable processes such as mammalian cell culture and harvest processes for upstream cell culture development.
- Designs scientifically rigorous experiments using statistical DoE where applicable and execution of experiments, analyze and interpret data to further craft next studies.
- Works closely with project leads to source and order equipment and consumables to perform bench and pilot scale seed train and production runs and build a state of the art pilot production lab
- 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 and pilot scale bioreactors)
- Works closely with project leads to draft standard operating procedures and master batch records for pilot scale batches, ensures all relevant information is recorded in a GLP / GDP compliant manner. Potential to lead upstream pilot scale production batches in the future with managerial responsibilities.
- Summarizes bench and pilot scale study results, reviews batch production records and drafts production summary reports
- Supports the creation and review of tech transfer protocol, supports the technical transfer of upstream unit operations to external manufacturing organizations
- Potential to be cross-trained for hands-on downstream process development and pilot scale production experience
- Supports the design and analyses of early and late stage process development and process characterization studies
- Provides oral project status updates and presentations to internal or external shareholders
- Aligns best practices and new technologies with needs of process development and manufacturing departments
- Works closely with Environmental Health and Safety and Quality to ensure lab work is performed in safe and compliant manner
WHO YOU ARE AND WHAT YOU BRING
- Minimum of BS/MS with 6+ years industrial
- Proven understanding of cGMP antibody upstream process development and production using CHO host cell expression systems at bench or pilot scale
- 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.
- Direct pilot/cGMP scale biomanufacturing experience is strongly preferred
- Good documentation practices (GDP) experience and experience writing standard operating procedures, batch records, and technical reports is preferred
This position is located in our San Francisco lab facilities and requires individuals to be onsite
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WHO WE ARE AND WHAT WE OFFER:
The expected salary range for this position is $93,000.00 to $122,000.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir's compensation and benefits are aligned with the current market and commensurate with your experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity and 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 onsite employees!
