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Principal Scientist, Process Development

Cambridge, Massachusetts, United States

About Stylus Medicine:

Stylus Medicine is developing transformative in vivo genetic medicines to unlock cures. Stylus combines engineered recombinases with non-viral delivery to specifically encode therapeutics. The company’s approach is versatile and modular, with potential therapeutic application across oncology, autoimmune, genetic diseases, and beyond.

About the Role:

Stylus Medicine is seeking an intellectually curious and collaborative Principal Scientist, who will lead the process development activities for nucleic acids and drive external manufacturing. The ideal candidate will have strong experience in developing scalable production processes for nucleic acids including DNA and/or mRNA. Within the role, the candidate will be responsible for process definition, development, characterization, scale-up and tech transfer from bench scale to Phase I GMP manufacture of the drug substance. This position will interface with cross-functional teams to progress new in vivo genetic medicines through the pipeline.

Key Responsibilities & Accountabilities:

  • Lead a high performing team to develop scalable production processes for nucleic acids
  • Leverage expertise in fermentation, high throughput screening, chromatography and filtration principles to advance novel in vivo genetic medicines across different stages of drug development
  • Screen, optimize and scale up production processes using design of experiments (DoE) principles
  • Work in close collaboration with the discovery team, formulation team and in vivo pharmacology team to support in vitro and in vivo experiments assessing safety and efficacy of the products produced
  • Spearhead internal innovation to improve nucleic acid quality and production yields that support commercially viable GMP scale up
  • Interface closely, as the primary point of contact, with CDMO organizations to execute and support technology transfers, manufacture and release of the drug substance
  • Discuss development program risks and/or experimental data with cross-functional teams to evaluate process performance, adjust development plans and ensure integrated program timeline success
  • Plan, organize, coordinate and lead activities to ensure progress of internal and external projects and their compliance to phase appropriate GLP and cGMP standards
  • Author study plans and reports and present findings at cross-functional team meetings

Qualifications & Skills:

  • PhD in Chemical or Biological Engineering, with 6 years of proven industry experience in leading process development, analytical characterization and scale up; or MS in Chemical or Biological Engineering, with 12 years of industry experience
  • Strong experience in process sciences, aseptic technologies, quality controls and technology transfer to CROs/CDMOs
  • Experience in supporting GMP manufacture and release of drug substance
  • Experience with IND filing and answering regulatory questions is a plus
  • Attention to detail and accuracy in developing and reviewing SOPs, batch records and technology transfer documents
  • Demonstrated ability to collaborate with multidisciplinary teams for successful outcomes
  • Demonstrated ability to coach and mentor junior researchers
  • Independently motivated and good problem-solving ability
  • Ability to work collaboratively across teams to meet project deliverables and timelines
  • Strong communication, decision-making and organizational skills

 

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