Sr. Scientist I, Combination Products
Core
Conceive and implement novel experimental approaches to support the development, scale-up, and commercial manufacturing of medical devices, drug-device delivery systems, and combination products.
Role type
Senior Scientist I, Combination Products (Hands-on IC)
Builds
Medical devices, drug-device delivery systems, and combination products for patient therapies
Domain
Biomedical engineering, pharmaceutical manufacturing, and combination product development
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
DOE design of experiments, process development and scale-up, risk assessment and test planning, regulatory compliance (FDA/ISO), technical documentation (SOPs/validation protocols), troubleshooting manufacturing deviations, cross-functional collaboration
Preferred skills
Ph.D. in biomedical/mechanical/chemical/materials science or engineering, post-doctoral experience, knowledge of Hyaluronic Acid hydrogels, wearable device battery design, pre-filled syringe/cartridge development, PMP certification
Technologies
Lab study execution tools, DOE software, manufacturing process control systems
Responsibilities
Design and execute experimental regimens to evaluate and validate drug delivery systems; support tech transfer and scale-up with CMOs; develop and review technical documentation including SOPs and validation protocols; assess risks and create test plans; troubleshoot manufacturing challenges and investigate process failures; prepare data summaries and presentations for cross-functional teams; ensure compliance with FDA and ISO standards.
Seniority
Senior, hands-on IC
