Scientist - Analytical Development
Location: Orange County, CA
Level: Scientist
SUMMARY
As a Scientist, Analytical Development for our global company, you will play a pivotal role in ensuring the quality, safety, and efficacy of our products. Working within a dynamic team of R&D experts, you will lead the development and optimization of analytical methods of novel small molecule therapeutics and APIs while working with quality control and our drug product development team. Your contributions will directly impact the advancement of our life-saving pharmaceutical products from discovery research to commercialization in a global capacity.
A Scientist - Analytical Development will have these responsibilities:
- of pharmaceutical materials with analytical techniques such as PAS, XRD, DSC, etc. on particle size distribution and crystallography to assess solid state chemistry of the materials.
- and execute validation protocols for analytical methods in accordance with regulatory guidelines (e.g., ICH, FDA, USP) to test purity and stability.
- a range of analytical techniques and instrumentations to analyze and characterize raw materials and finished drug products.
- wet chemistry techniques and different assays for the physical and chemical characterization of APIs, raw materials, and drug products.
- and conduct release and stability studies to assess drug substances and finished products under various storage conditions, ensuring compliance with regulatory requirements.
- updated with global regulatory guidelines and ensure that analytical methods meet the stringent quality standards required for regulatory submissions.
A Scientist - Analytical Development has the following qualifications:
Ph.D., M.Sc., or B.Sc. w/ 3-8+ years' experience in a pharmaceutical industry
- Proficient experience with solid-state chemistry, PAS, XRD, method development, method validation, & method transfer
- Additional experience in regulatory filing is a plus
BENEFITS
- Bonus
- 401k with company matching
- Dental, Vision
If you're interested in this new and innovative opportunity, please apply by clicking here.
