Analytical Expert PDS&T (F/H/X)
Core
Analytical expert supporting process and product development for biologics from IND to BLA and commercialization phases.
Role type
Senior analytical expert (biologics)
Builds
Bioanalytical and physico-chemical methods for therapeutic biomolecules
Domain
Biopharmaceuticals / Biologics
Required skills
bioanalytical method development, physico-chemical analysis, regulatory compliance (BPF, USP, ICH), 21 CFR part 11, analytical reporting
Preferred skills
none stated
Technologies
ELISA, qPCR, liquid chromatography, electrophoresis, mass spectrometry, uHPLC, CE-SDS, cIEF
Responsibilities
Represent the team in analytical support for process activities (USP and DSP) at lab and production scale; Serve as the scientific analytical reference for project teams developing biomolecules in clinical phases I-III and pre-commercial stages; Define and coordinate bioanalytical and physico-chemical laboratory activities; Ensure method development and implementation activities within deadlines and budgets while adhering to quality standards
Seniority
Senior, hands-on IC
