Irvine, California, 92606
Job description
**Job Title: Senior Scientist**
The Senior Scientist is responsible for spearheading analytical development initiatives, which encompass method validation, risk evaluation, and the formulation of control strategies for drug programs in clinical phases. This role involves offering scientific guidance to external laboratories and aiding in the preparation of regulatory chemistry, manufacturing, and controls (CMC) documentation. Qualified candidates will possess a PhD with at least 4 years of relevant experience or an MS accompanied by 8 to 12 years in a related scientific field. A deep understanding of ICH, FDA, and cGMP regulations, along with a background in analytical CMC related to clinical development, is essential.
STEMHUNTER is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, and gender expression), national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law. We comply with all applicable equal employment opportunity and affirmative action regulations.
