Senior Scientist, Upstream Process Development

About the Company

Stylus Medicine is developing transformative in vivo genetic medicines to unlock cures. The company combines engineered recombinases with non-viral delivery to specifically encode therapeutics, with potential applications across oncology, autoimmune, and genetic diseases.

Responsibilities

• Develop scalable production processes for nucleic acids and recombinant proteins
• Leverage expertise in fermentation and mammalian cell culture to design, optimize, scale-up and characterize production processes
• Utilize multivariate design of experiment (DoE) approaches to improve productivity and optimize parameters
• Drive fermentation platform development and new technology implementation
• Design and implement in-process analytics to improve productivity and reduce impurities
• Maintain and troubleshoot equipment to ensure continuity of operations
• Document, analyze and present experimental results internally and externally
• Partner with CDMOs and provide technology transfer support to facilitate scale up
• Interface with cross-functional teams to ensure programs are on track
• Maintain accurate record keeping including database management, batch records, and notebooks

Requirements

• PhD in Chemical/Biomedical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline with >4 years of experience, or BS/MS with >8 years of experience
• Experience in biopharmaceutical or biotechnology development, specifically scalable fermentation processes for plasmid DNA and/or recombinant products
• In-depth knowledge in fermentation process development, optimization, and scale-up/scale-down model development
• Familiarity with strain engineering and biocatalysis
• Experience performing operations in a cleanroom environment with aseptic processing controls
• Demonstrated ability to coach and mentor junior researchers
• Strong communication, decision-making, and organizational skills

Preferred Qualifications

• Proficiency with statistical analysis software such as JMP
• Prior experience partnering with external CDMOs and conducting tech transfers