Job Description - LifeMine Therapeutics, Inc. is the first biotechnology company exploiting the unique ability of fungi to produce powerful drugs optimized through billions of years of evolution and deploying these molecules for the treatment of intractable human diseases via novel biological mechanisms. The company is using a genome mining and recombinant overexpression approach to mount a massive search for novel drugs through the fungal biosphere. With operations in Cambridge and Gloucester, Massachusetts, LifeMine brings a unique approach to its revolutionary scientific and medical mission.We are seeking an industry-experienced professional to lead the development of robust and scalable, filamentous fungal fermentation and downstream processes for production of natural products in support of LifeMine’s genomically-enabled drug discovery platform.
Responsibilities - •Lead internal fermentation capability for filamentous fungi for the cost-effective, large-scale production of secondary metabolites •Implement economical fermentation and scale-up processes from shake-flasks to large-scale bioreactors by applying quality by design (QbD), scientific and engineering principles, as well as statistical process design and analysis •Plan and execute expansion of current fermentation capacity to meet future bioprocess demands at LifeMine •Manage bioprocess technology transfer to external manufacturing partners •Ensure the fermentation site is compliant with all regulatory, cGMP and quality requirements •Apply current industry best practices, proactively evaluate new technologies, stay current with relevant literature, and implement new features and functionality in the bioprocess development platform •Engage in close, cross-functional collaborations with LifeMine’s Genomics, Strain Engineering, Microbiology, Natural Product Chemistry, and Bioinformatics groups to interpret data, reach conclusions, and make decisions
Qualifications - •MS or PhD in chemical engineering or a related field with 10+ years of industrial experience in fermentation bioprocess development •Proven track record of industrial fermentation expertise with bioreactors at multiple scales using filamentous microbes (filamentous fungal experience highly preferred) •Extensive expertise with fermentation process design, optimization (DOE), and mixing/mass transfer using filamentous microbes •Fermentation process scale-up experience, i.e. ability to translate laboratory success to commercial manufacturing•In-depth knowledge and working experience with applying Quality by Design (QbD) concepts and statistical process design and analysis (e.g., JMP; SpotFire) •Ability to identify complex problems, review data to determine root cause, evaluate options and implement solutions•Proven experience in budgeting and capital investment projects•Knowledge of cGMP’s, regulatory guidelines, validation practices, and other relevant regulatory requirements •Technical leadership supporting risk assessments (including Design Qualification, Job Hazard Assessments, Process and Quality Risk Assessments) •An understanding of Six Sigma and lean manufacturing principles •Embraces ideas of others, nurtures innovation and manages innovation to reality •Builds strong relationships with peers and cross-functionally with partners outside of team to enable higher performance
Job Confirmation # - 204784313
Website - lifeminetx.com
Email - firstname.lastname@example.org