Senior Analytical Scientist
Core
Design and perform experiments to develop, validate, and transfer analytical methods for pharmaceutical drug substance and drug products.
Role type
Senior IC analytical scientist (pharmaceutical development)
Builds
Analytical methods and control strategies for vaccines and medicines
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Method development, Method validation, Pharmacopeia compliance, Analytical lifecycle management, Assay development, Stability testing, Experimental data interpretation, Technical writing, Regulatory documentation, Laboratory troubleshooting
Preferred skills
cGMP requirements, Small molecule API development, ADC drug linker intermediate development, FDA/EU/UK/ICH regulations, HPLC/UPLC/GC/UV/Vis/KF/MS techniques, CRO/CDMO collaboration, Electronic Lab Notebook (ELN) systems, Data Analytics (SQL, PowerBI, Spotfire)
Technologies
HPLC, UPLC, GC, UV/Vis spectrophotometry, KF, MS, Waters Empower CDS, Electronic Notebook system, SQL, PowerBI, Spotfire
Responsibilities
Develop and perform assays for development, release, and stability testing; Document laboratory work in accordance with GxP expectations; Review experiments, stability protocols, and key documentation; Contribute to patents and regulatory submissions; Troubleshoot experimental processes and interpret results; Provide scientific input for analytical control strategies
Seniority
Senior, hands-on IC
