Stylus Medicine

Senior Scientist, Upstream Process Development

Cambridge, Massachusetts, United States · Senior

Sponsorship not specified$155k-$170kDetected 106 days ago

StatisticsCell CultureResearchAnimal StudiesCommunicationProblem SolvingOrganizational SkillsFermentation

About the role

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.
Interface with cross-functional teams to ensure programs are on track and stakeholders' needs are met

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
Maintain accurate and reliable record keeping including database management, batch records, notebooks, and all other pertinent documentation

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
Attention to detail and accuracy in developing, reviewing, and following protocols, SOPs, batch records and technology transfer documents is a must

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
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
Qualifications & Skills:

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.

This listing is sourced directly from Stylus Medicine's careers page and normalized into a canonical job model.