Associate Scientist, Analytical Development, Pharmaceutical Sciences
Core
Develop and validate analytical methods for pharmaceutical candidates to ensure quality and support regulatory submissions.
Role type
Associate Scientist, Analytical Development
Builds
Validated analytical methods and quality assurance data for drug candidates
Domain
Biopharmaceuticals / Analytical Chemistry / GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development, Analytical method validation, Stability testing, cGMP compliance, ICH guidelines knowledge, Laboratory equipment operation, Inventory management, Technical documentation, Regulatory application support, Data integrity
Preferred skills
Experience with biologics (antibodies, nucleic acids, peptides), Experience with clinical trial materials, English business communication, Japanese business communication
Technologies
HPLC, ELISA, PCR, Laboratory Information Management Systems (LIMS)
Responsibilities
Conduct GMP quality testing for drug candidates, Perform environmental monitoring and microbiological testing, Develop and validate analytical methods for clinical trial materials, Manage quality events and deviations, Maintain laboratory inventory and equipment, Create standard operating procedures and technical documentation
Seniority
Junior to Mid-level, hands-on IC
