Senior Scientist, Upstream Process Development

About the Role:

Stylus Medicine is seeking an intellectually curious and collaborative Senior Scientist, who will lead the development of upstream microbial fermentation processes as part of our CMC Tech Ops team. This role will be responsible for process definition, development, characterization, scale-up and tech transfer from bench scale to pilot. Working closely with the Research, Preclinical, and Formulation teams, this is a special opportunity to advance the development of transformative in vivo genetic medicines.

Key Responsibilities & Accountabilities:

• 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
• Independently utilize multivariate design of experiment (DoE) approaches to improve productivity and optimize parameters for product quality
• Drive fermentation platform development and new technology implementation to improve process performance, generation of predictive process models, and enhance process control and robustness
• Design and implement in-process analytics to improve productivity while reducing process and product derived impurities
• Maintain and troubleshoot equipment to ensure consistency and 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 and stakeholders’ needs are met
• Maintain accurate and reliable record keeping including database management, batch records, notebooks, and all other pertinent documentation

Qualifications & Skills:

• PhD in Chemical/Biomedical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline with >4 years of experience, or BS/MS with >8 years of experience in biopharmaceutical or biotechnology development, including experience in developing scalable fermentation processes for producing plasmid DNA and/or recombinant products
• In-depth experience and knowledge in fermentation process development, optimization, and process scale-up / scale-down model development
• Familiarity with strain engineering and biocatalysis
• Familiarity with performing operations in a cleanroom environment, applying controls to ensure aseptic processing
• Demonstrated ability to coach and mentor junior researchers
• Independently motivated and good problem-solving ability
• Attention to detail and accuracy in developing, reviewing, and following protocols, SOPs, batch records and technology transfer documents is a must
• Demonstrated ability to work collaboratively across teams to meet project deliverables and timelines
• Strong communication, decision-making and organizational skills
• Proficiency with statistical analysis software (e.g., JMP) is highly desired
• Prior experience partnering with external CDMOs and conducting tech transfers preferred

Pay Range: $155,000 - $170,000