Analytical Lead and Expert Preclincal Bioassays (all genders)
Core
Lead analytical activities and bioassays for late-stage and commercial biologics, supporting product launches and regulatory dossiers.
Role type
Senior IC analytical lead (biopharma)
Builds
Biologics products (insulin, vaccines, medicines)
Domain
Biopharmaceuticals / Analytical Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
analytical transfer, bioassay development, automation, regulatory dossier writing, cGMP compliance, risk assessment, comparability studies
Preferred skills
method validation, external supplier coordination, regulatory authority interaction
Technologies
bioassays, automation systems
Responsibilities
Coordinate and follow-up on experiments at external suppliers for bioassays; Lead ALCM activities including assay development, transfer, and SME support; Provide input to regulatory dossiers and respond to authority questions; Develop analytical control strategy specifications and risk assessments for new product introductions.
Seniority
Senior, hands-on IC
