Chemist, Product Development
Core
Develop and validate chemistry methods and test procedures for medical device products to support R&D and manufacturing transfer.
Role type
Product Development Chemist (Analytical)
Builds
Validated chemistry test methods and equipment qualifications for medical devices
Domain
Medical Technology / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
analytical chemistry, organic chemistry, HPLC, wet chemistry, spectroscopy, titration, method validation, equipment qualification (IQ/OQ/PQ), experimental design, data analysis, troubleshooting
Preferred skills
LC-MS, GC-MS, FTIR, ICP-MS, particulate matter testing, extractables testing, elemental impurity testing, statistical analysis, 21 CFR Part 11 compliance, USP/ICH standards knowledge
Technologies
HPLC, LC-MS, GC-MS, FTIR, ICP-MS, titration equipment, spectroscopy instruments
Responsibilities
Develop and complete validations for chemistry test methods and equipment; interface with cross-functional teams for product development; maintain complex laboratory equipment; establish SOPs and best practices; analyze and present findings in team meetings; prioritize and plan test plans; ensure laboratory safety and EHS compliance; cross-train peers
Seniority
Mid-level, hands-on IC