Senior Scientist, I
Core
Conceive and implement novel experimental approaches to support the development, scale-up, and commercial manufacturing of medical devices, drug delivery systems, and combination products.
Role type
Senior Scientist (Product Development & Process Engineering)
Builds
Medical devices, device-drug delivery systems, and combination products for commercial manufacturing
Domain
Biomedical engineering, pharmaceutical manufacturing, and medical device technology (via careerplan.io/jobs/3743990015903936-senior-scientist-i-at-abbvie)
Required skills
DOE design of experiments, process development and optimization, scale-up activities, risk assessment, regulatory compliance (FDA/ISO), technical writing, problem-solving, cross-functional collaboration
Preferred skills
Ph.D. in biomedical/mechanical/chemical/materials science or engineering, experience with pre-filled syringes/cartridges, wearable medical devices, auto injectors, Hyaluronic Acid hydrogels, wearable device batteries, PMP certification
Technologies
Lab study execution tools, design verification and validation frameworks, standard operating procedures (SOPs), batch records, validation protocols
Responsibilities
Design and execute experimental tests to evaluate and validate systems; develop and optimize manufacturing processes; troubleshoot manufacturing challenges and investigate deviations; prepare technical documentation and presentations; collaborate with CMOs and cross-functional teams; assess risks and create test plans; ensure compliance with industry standards and regulations
Seniority
Senior, hands-on IC