Scientist - Process Development
Fremont, CA | Direct Hire
Bayside Solutions is seeking a Scientist of Process Development to be a part of our partner’ s growing Process Development team in the San Francisco East Bay Area. This is an opportunity to work with a biotech company on the frontier of rejuvenation therapeutics.
Our partner’ s culture is based on a team based work environment. They are passionate about the product and end goal; they believe in the work they are conducting. This translates into a tight knit group of individuals who contribute to a common goal. No task is too small or too large; everyone puts effort in all aspects of the laboratory. The group puts in the long hours to achieve one common goal.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Scientist – Process Development
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases
- Work for a company that is local to the bay area and recognized as a leader of innovation
- Competitive compensation commensurate with experience
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K
Summary of Responsibilities
- Execute the refinement and optimization of current processes for scaling up purposes to a large scale manufacturing operation using undifferentiated human embryonic stem cells: including but not limited to regular passaging of cells, thawing and freezing cell lines, cell banking and processing samples
- Optimize formulations & final processing schemes for final delivery to patients
- Solve technical issues and evaluate and implement new technology/instrumentation based on scientific literature and industry trends as well as requirements for GMP production
- Present and discuss experimental findings in lab and departmental meetings
- Train new hires on the process of culturing hESC and differentiation into different products
- Conduct daily activities such as working within a hood, the preparation of cell culture raw materials, monitoring, sampling and documenting of cell culture performance, regular passaging of cells, thawing and freezing cell lines, cell banking and processing samples.
- Generate, manage, evaluate, and maintain complete and accurate laboratory documentation and critical data in electronic files
- Operates, maintains, and troubleshoots lab and cell culture equipment
- Draft and review technical documents such as batch records and reports
- Work cross functionally with Process Development, Research, and Analytics
- Create process sampling plan to monitor process development activities and optimization through adequate sample archives
- Engineer with a PhD in Chemical Engineering, or Biomedical Engineering with a mixture of five to eight years’ experience with a pharmaceutical or biotechnology company and in an academic setting.
- Industry experience in a PD/Manufacturing environment working with mammalian cell culture.
- Exposure to techniques to support closed processing of manufacturing steps such as tube welding, media bags, and bioreactor operation a plus.
- Will need to have worked with mammalian primary cell culture specifically cells grown by attaching to cell culture plastic.
- Exposure to stem cell culture would be a plus.
- A bioengineering background would be a plus.
- Experience with scale up processes and equipment such as bioreactors for growing cells, closing down processes, cell harvesting, cell formulation for cryoprocesses, vialing for frozen storage etc.
- Aseptic human embryonic stem cell culture mandatory.
- Culturing for surface anchorage or adherent dependent cells within manufacturing, quality, and operation processes.
- Must be open in regards to extended hours, weekends, and holiday work schedules.
- Critical thinking and critical observation skills; must be proactive in decision making.
- Strong experience with documentation; ie batch records.
- Experience process equipment such as bioreactors, vial cells, cryopreserved cells, multilayer cells, shake flasks, and continuous centrifuges a plus.
- Must have strong drive for regenerative therapeutics.
- Developing devices such as an injectable for 2D adherent cell culture a plus.
- JMP® DOE or other statistical software a plus.