Principal Scientist, Process Development

Principal Scientist, Process Development Principal Scientist, Process Development Get AI-powered advice on this job and more exclusive features. 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 Applicants can submit their resumes to careers@stylusmedicine.com Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Stylus Medicine by 2x Get notified about new Process Development Scientist jobs in Greater Boston . Clinical Scientist, Clinical Development Waltham, MA $140,000.00-$155,000.00 1 week ago Greater Boston $104,900.00-$140,100.00 3 weeks ago Senior Scientist, Analytical Development (Chemistry). Cambridge, MA $112,000.00-$130,000.00 3 days ago Principal Scientist , Analytical Science Lead Protein Scientist, Analytical and Formulation Dev. Biologics Scientist/Senior Scientist, Chemical Development and Manufacturing Principal Scientist – Small Molecule Process Development Process Development Senior Scientist, Late-Stage Drug Product Development Principal Scientist, Drug Product Development Cambridge, MA $149,858.00-$185,119.00 2 weeks ago Research Scientist I, Analytical Development Senior Scientist, Synthetic Enabling Technologies Cambridge, MA $100,500.00-$145,166.66 2 days ago Cambridge, MA $156,000.00-$296,500.00 2 weeks ago Principal Research Scientist II, Analytical Development ( On-site, Waltham MA) Waltham, MA $137,500.00-$261,000.00 12 hours ago Senior Principal Research Scientist, Analytical Chemistry Cambridge, MA $156,000.00-$296,500.00 2 weeks ago Senior Scientist Analytical Development – Molecular-based assays – Automation & Testing Boston, MA $124,400.00-$186,500.00 2 weeks ago Senior Principal Research Scientist, Analytical Chemistry Worcester, MA $156,000.00-$296,500.00 2 weeks ago Senior Scientist, CMC Analytical Development Senior Scientist, Pharmaceutical Development CMC (CONTRACT) Analytical Science and Technology Senior Scientist Scientist 3/Senior Scientist, Clinical Pharmacology We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr