Fermentation Process Development Engineer - PhD Level

Eurofins USA PSS Insourcing Solutions•San Carlos, CA

3d•Onsite

About The Position

Eurofins PSS is seeking an experienced scientist with a fermentation development background to assist in leading the development and scale-up of E. coli fermentation processes at the front end of a novel, proprietary DNA manufacturing platform. Working at bench and pilot scale, the successful candidate will own the upstream unit operation end to end: designing the studies, running the bioreactors, interpreting the data, and converting what you learn into a process that is higher-yielding, more consistent, and robust enough to transfer to an external manufacturing partner. The new hire will work closely with molecular biology, downstream purification, and analytical development, so that upstream decisions are made with full visibility into their downstream consequences. The documentation you generate will form the basis of the packages that support GLP studies and technology transfer to external partners.

Requirements

Demonstrated experience scaling a microbial process from bench to pilot or manufacturing scale, including the comparability and documentation work that accompanies it.
Experience with high-cell-density fed-batch E. coli fermentation and the practical constraints that come with it: oxygen transfer limitation, heat removal, acetate accumulation, and foam control.
Molecular cloning and construct design experience sufficient to engage substantively with strain and vector design decisions rather than receiving them as fixed inputs.
Hands-on proficiency with a modern bioreactor control platform (for example Sartorius, Eppendorf/DASGIP, or Ambr) and with parallel or high-throughput bioreactor systems.
Strong written and verbal communication skills, with the ability to make technical arguments clearly to both specialist and non-specialist audiences.
Self-management and a results orientation suited to a small, fast-moving team where priorities shift and scope is not always fully defined at the outset.
PhD in chemical engineering, biochemical engineering, biotechnology, microbiology, molecular biology, or a related field
1+ years of hands-on experience developing and operating bacterial fermentation processes in instrumented, controlled bioreactors.
Demonstrated experience independently designing, executing, and analyzing fermentation experiments at ≥ 2 L working volume.
Demonstrated experience applying design of experiments and statistical analysis to process development data.
Demonstrated technical writing experience, evidenced by authored development reports, technical protocols, or peer-reviewed publications.
The role involves work with genetically modified E. coli at BSL-1 containment and requires the ability to operate pressurized and rotating equipment in accordance with site EHS requirements

Nice To Haves

Prior work on plasmid DNA or other nucleic acid products, where key product quality attributes are set in large part by the fermentation itself rather than recovered downstream.
Proficiency with DOE and statistical software (for example JMP or Design-Expert), and comfort using Python or R for data handling and visualization.
Experience generating documentation for GLP studies or other regulated activities.
Experience with technology transfer to CDMOs, including the practical realities of working to a partner’s equipment train and quality system.

Responsibilities

Design, execute, and optimize E. coli fermentation processes from shake flask through bench-scale and pilot-scale bioreactors, owning the experimental work hands-on.
Drive measurable improvements in yield and batch-to-batch consistency through systematic optimization of host strain performance, media composition, feed strategy, induction conditions, and control setpoints for pH, dissolved oxygen, temperature, and agitation.
Using design of experiments, define the process design space and identify the critical process parameters that govern product quality and quantity, rather than relying on one-factor-at-a-time work.
Establish scale-independent criteria (volumetric power input, oxygen transfer capacity, mixing time, and gas-phase mass balance) so that performance demonstrated at bench scale is reproducible at pilot scale and beyond.
Develop clear, pre-specified experimental plans, analyze and interpret the resulting data with appropriate statistical rigor, and present conclusions and recommendations to cross-functional teams and leadership.
Author thorough technical documentation (protocols, development reports, process descriptions, and process history) to a standard that will withstand external review.
Generate the documentation packages needed to support downstream GLP studies and technology transfer to external partners and CDMOs, and support those partners through process fit assessments, engineering runs, and on-site execution.
Collaborate closely with molecular biology, downstream purification, analytical development, and quality colleagues, translating engineering constraints for biologists and biology constraints for engineers.
Lead technical investigations when runs deviate from expectation, working from first principles and data rather than assumption to identify root cause and define corrective actions.
Own operation, maintenance, calibration, and qualification of fermentation equipment and associated instrumentation, and maintain a safe, compliant laboratory in line with company and EHS requirements, including applicable biosafety practices.
Maintain a working knowledge of the external fermentation and nucleic acid manufacturing literature and bring relevant new approaches into the platform.