Senior Chemist - Analytical Development
- Location: Orange County, CA
- Level: Senior Chemist
SUMMARY
As a Senior Chemist - 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.
A Senior Chemist - Analytical Development will have these responsibilities:
- Design and execute validation protocols for analytical methods in accordance with regulatory guidelines (e.g., ICH, FDA) to ensure accuracy, precision, specificity, and robustness.
- Develop and validate methods using a range of analytical techniques and instrumentation, such as HPLC, GC, LC-MS, FTIR, NMR, and dissolution testing
- Analyze and characterize raw materials and finished drug products.
- Plan and conduct stability studies to assess the stability of drug substances and products under various storage conditions, ensuring compliance with regulatory requirements.
- Experience with statistical data analysis and software tools (e.g., JMP, ChemStation) for method validation and optimization.
- Staying updated with global regulatory guidelines and ensure that analytical methods meet the stringent quality standards required for regulatory submissions
- Oversee the troubleshooting, calibration, and qualification of analytical instruments, ensuring their accuracy and reliability in data generation
A Senior Chemist - Analytical Development has the following qualifications:
- M.Sc. or B.Sc. w/ 4-6+ years' experience in a pharmaceutical industry
- Proficient experience with Method Development/Validation; HPLC, GC, UV-Vis, & Particle Size Analysis in cGMP setting
- Additional experience preferred: regulatory filing experience
BENEFITS
- Annual Bonus
- Competitive 401k with company matching
- Medical, Dental, Vision
If you're interested in this new and innovative opportunity, please apply by clicking here.
