Analytical Expert
Core
Lead analytical science and technology for product portfolio, ensuring compliant, robust methods and driving transfers, validations, and stability studies for biopharmaceuticals.
Role type
Senior Analytical Science & Technology Expert (SME)
Builds
Reliable analytical methods, validated processes, and stable commercial products for rare disease treatments
Domain
Biopharmaceuticals / Analytical Chemistry / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical chemistry/biochemistry/pharmacist/chemical engineering expertise, biological drug analysis, method validation, tech transfer, stability study management, reference standards handling, HPLC/spectroscopy/ELISA/bioassay proficiency, CMO collaboration
Preferred skills
Life Science/Pharma industry experience with commercial products
Technologies
HPLC, spectroscopy, ELISA, bioassay
Responsibilities
Act as Analytics SME for overall responsibility of analytical methods and related work; Responsible for analytical method transfers, validations, and supporting product stability and shelf life; Establishment and maintenance of reference materials and product specific method standards; Ensure life cycle management, compliance, robustness, and relevance of analytical methods; Act as SME in regulatory filing, new launches, and commercial product supply; Support investigations of deviations, changes, CAPAs, complaints, OOT, and OOS
Seniority
Senior, hands-on IC
