Lead process development initiatives in a regulated environment focused on sample preparation/preanalytical activities associated with biofluid processing (primarily blood), PBMC isolation, DNA/RNA extraction, and various forms of sample aliquoting
Develop, test, validate, and train new and improve existing methods.
Work with automation team to design, test, and validate new/improved automation methods
Design fit-for-purpose validations based on client needs
Proactively recommend process improvements
Draft/modify SOPs and validation documents for new and improved processes
Assist with project deliverables as needed
Qualifications (knowledge, skills, experience, abilities, and other requirements):
M.S. with 4+ years of industry experience, P.h.D. with 2+ years of industry experience
Must have experience working in a regulated environment (GxP, GLP, GCP, CLIA/CAP, etc)
Must have experience developing and validating methods in a regulated environment
Experience with handling blood, aseptic technique, and/or various forms of nucleic acid extraction highly desirable
Experience working with and comfortable around automation
Results-driven, go-getter who is a strong individual contributor but also operates well across teams
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