Senior Scientist, Product Development

South San Francisco, CA. On-site. Reports to the CTO. Spiral is a clinical-stage biotech working on hearing loss and balance disorders, a field with very few approved therapies. Our lead program, SPT-2101, is a minimally invasive dexamethasone treatment for Ménire's disease, and we are building a pipeline behind it. The team is small, so will own formulation across the company. The work You'll run formulation development for new programs from pre-formulation through clinical manufacturing, across small molecules, peptides, and proteins. A big piece of it is designing, characterizing and building delivery platforms that get drug into the inner ear. You'll also set analytical strategy, develop methods and product specs, build manufacturing processes, and work with our CMOs through manufacture and testing. You will own the CMC timelines, decision points, and regulatory sections. Who we\'re looking for PhD in Pharmaceutical Sciences, Analytical Chemistry, Chemical Engineering, Materials Science, or a related discipline. Equivalent experience is fine. 3 to 8 years in formulation development and drug product manufacturing, with real time at the bench. Solid command of analytical testing requirements, ideally including method development. Working knowledge of GMP and the regulatory requirements around formulation and manufacturing. Experience with extended-release or controlled delivery systems is what we\'re most hoping to find. Protein formulation and prior supervisory experience are both welcome. Previous supervisory experience is a plus. Practical stuff Lab and manufacturing environment. Occasional travel. Reasonable accommodations available. Lab work happens at our formulation lab in South San Francisco. Everything else is at the office nearby or remote, depending on the project. #J-18808-Ljbffr Spiral Therapeutics