- Irvine, California, United States
- On-site
- Full-time · Principal
- $160K–$190K per year
- 8+ years
Lead hands-on method development, validation, and stability studies supporting advanced drug delivery systems.
Compensation
$160,000 - $190,000 based on experience and qualifications, along with an Annual Bonus opportunity.
Responsibilities
- Lead the hands-on, in-house development, feasibility, validation, and transfer of critical analytical methods and procedures supporting clinical-stage ophthalmic drug delivery platforms.
- Collaborate with cross-functional teams, including formulation development, process development, regulatory affairs, and quality assurance, to ensure alignment with product development goals.
- Design and execute phase-appropriate analytical development plans to deliver high-quality, compliant data from preclinical evaluation through clinical trials and final marketing approval.
- Prepare, review, and approve analytical protocols, reports, and sections of regulatory submissions to ensure accuracy, completeness, and compliance.
- Conduct stability studies for development and GMP batches, ensuring compliance with regulatory requirements and supporting specifications and shelf-life determinations.
Requirements
- PhD in pharmaceutical sciences
- Analytical chemistry