Group Leader, BioChemical Analysis
Core
Manage a sub-team of junior scientists and act as a technical expert for analytical activities in Biopharma product development under cGMP regulatory guidance for large molecules and biologics.
Role type
Senior IC Group Leader, BioChemical Analysis
Builds
Analytical methods, data, and stability studies for biopharma products
Domain
Biopharmaceuticals / Biochemical Analysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Method development and validation, cGMP compliance, team leadership and mentoring, project management, regulatory milestone strategy, instrumentation expertise, data interpretation
Preferred skills
Drug development lifecycle knowledge, new technology assessment, cross-functional liaison
Technologies
HPLC, GC, Mass Spectrometry, Bioreactor monitoring, Stability testing equipment
Responsibilities
Plan and execute analytical work per client contracts; ensure data integrity via SOP/GMP adherence; mentor associates and conduct performance reviews; support client audits; identify and implement new technologies
Seniority
Senior, hands-on IC with team management
