Expert, Technical Development
Core
Design, plan, perform, and interpret scientific experiments for the development and validation of analytical methodologies for innovative oligonucleotide/peptide therapeutics.
Role type
Senior IC analytical development scientist (oligonucleotide/peptide)
Builds
Robust analytical methodologies and validated testing protocols for drug substances and products
Domain
Pharmaceutical/Biologics (Oligonucleotides/Peptides)
Required skills
Analytical chemistry, GMP compliance, Liquid chromatography (RP, IEX, HILIC), Mass spectrometry, Method validation, Data documentation (LIMS), Regulatory knowledge
Preferred skills
Process simulation, Materials science, Technical writing, Waterfall model
Technologies
Chromeleon, LIMS, Office package
Responsibilities
Perform method feasibilities and validate robust analytical methodologies; Plan, organize, execute, and document scientific experiments (method development, validation, transfers, stability, release testing); Support evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls; Manage assigned laboratory activities including chemical/reagents/consumables management; Meet KQI and KPI for all assigned activities; Support internal and external audits. (via careerplan.io/jobs/REQ-10089092-expert-technical-development-at-novartis)