Expert Analytique PDS&T (F/H/X)
Core
Support analytical activities for process development and product lifecycle from IND to BLA for biological therapeutics.
Role type
Senior analytical expert (biologicals)
Builds
Analytical methods and quality control for biologic drug development
Domain
Biopharmaceuticals / Biological therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ELISA, qPCR, liquid chromatography, electrophoresis, mass spectrometry, 21 CFR part 11 compliance, regulatory document writing
Preferred skills
None stated
Technologies
ELISA, qPCR, liquid chromatography, electrophoresis, mass spectrometry
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 bio-analytical and physico-chemical method development activities; Ensure method development and implementation activities meet deadlines, budgets, and quality standards.
Seniority
Senior, hands-on IC
