Senior Process Engineer (Cell Culture) – Emerging Biotech/Top $$ (Will Relo/NC)
Our client, a Research Triangle Park, NC–based biotechnology company, has gained worldwide attention (and funding) for the work it is doing to bring cell-cultured human milk to market. This is revolutionary technology for which there is infinite demand. Investors include some of the top venture capitalists in the market, including Bill Gates’s Breakthrough Energy Ventures.
This Process Engineer will be instrumental in helping to achieve its mission. S/he will be critically involved in developing and scaling up the technology. It is an essential role and company will pay generous wage, including relo, to attract and retain an excellent candidate.
Key Things to Note:
- The company’s patented technology produces nutritionally equivalent breastmilk from cultured human mammary cells. This milk, intended to be as nutritional as breastmilk, will offer the convenience of infant formula.
- To date the technology has been able to produce small quantities of milk. This Process Engineer will work in partnership with other engineers and scientists to expand the capabilities, in a safe and effective way. Strong background in cell culture is expected. Experience scaling from bench-top to full production is preferred.
- This role will involve in product/process design as well as optimization. Seek candidate who brings a strong data-driven, statistical analysis skillset as well as experience with capital equipment commissioning.
- This is a start-up setting. Employees are hands-on, mission-driven, empowered, collaborative, resourceful, flexible and can-do. We seek go-getters who bring a similar, get-it-done-right work style.
- This is a hybrid role – with time split between on-site and at-home work.
This Process Engineer will be involved in a wide range of design and process improvement manufacturing efforts including:
- Improving cell culture standard operating procedures by working hands-on with operators on the process, assessing pain points and implementing process changes to:
- increase first pass yield
- reduce rejects
- improve cost
- Reduce consumable cost (cartridges, media, growth factors) by surveying commercially available options and preparing make-versus-buy analyses.
- Implement changes and verify that the changes did not negatively impact the process
- Identify and share continuous improvement suggestions for team processes and equipment utilization
- In partnership with operations, culture mammalian cells on flasks and HFB cartridges. Perform biochemical assays to measure cell proliferation and expression.
- Lead relationships with external vendors (universities, commercial labs) to perform analyses that cannot be performed in-house
We seek candidates with the demonstrated ability to perform statistical analyses and interpret data for actionable decision-making as well as the ability to bring rigor to the assessment of experimentation and production to adjust variables for better results.
Targeted candidates will offer a related Engineering degree and 2+ years of experience developing or improving manufacturing processes using 2D & 3D cell culture, statistical process control and bioreactor optimization.
Other priorities include
- Experience scaling a bioprocess from bench-top to full production
- Experience sourcing, commissioning, and qualifying capital equipment
- Familiarity with cGMP process equipment and unit operations such as cell culture, bioreactors, filtration, chromatography, sterilizers, incubators, etc.
- Ability to troubleshoot process equipment issues and implement solutions
- Ability to analyze and synthesize conclusions from large datasets via statistics software
- Hands-on experience with many of the following techniques: mammalian cell culture, hollow fiber bioreactor operation, fermentation technology, hollow fiber bioreactor process development, and bioreactor data analysis, depth filtration, TFF, ATF, precipitation, cell culture, and bioreactor systems for mammalian protein production
- Familiarity with the production of monoclonal antibodies, the related bioreactors, and upstream processing equipment
- Awareness of biochemistry techniques including lysate preparation, electrophoresis, Western blotting, and 'metabolomic' analyses; enzymatic or immunological assays such as ELISA; biological specimen preparation, including histological sectioning, immunohistochemistry, immunofluorescence, wide-field and confocal microscopy, flow cytometry and cell sorting
Finally, we seek an Engineer who will thrive in this start-up setting; someone who can work through ambiguity to get to smart solutions; someone who can switch readily and stay focused on a goal; someone who can contribute broadly and support others; someone who is eager to bring this dream to life.
This is an immediate need. Please forward Word resume for prompt consideration.