I am seeking a Sr. Scientist/Associate Director for Analytical Development in San Diego, CA, with a salary range of $160k-195k. This on-site role involves leading analytical chemistry development activities for clinical-stage programs, guiding CMC efforts, developing and validating test methods, and managing outsourced QC testing. The candidate will collaborate cross-functionally to establish specifications and control strategies, characterize process impurities and degradation products, oversee solid-state characterization studies, manage ICH stability programs, prepare RFPs, and manage analytical development at CDMOs and contract labs. Additionally, they will author CMC analytical sections in regulatory filings.
Position: Sr. Scientist/Associate Director, Analytical Development
Location: San Diego, CA (on site)
Salary Range: $160k-195k
Responsibilities:
- Lead analytical chemistry development activities across clinical-stage programs.
- Guide internal and external CMC efforts.
- Develop and validate test methods, manage outsourced QC testing.
- Collaborate cross-functionally to establish specifications and control strategies.
- Characterize process impurities and degradation products.
- Oversee solid-state characterization studies.
- Manage ICH stability programs.
- Prepare RFPs and manage analytical development at CDMOs and contract labs.
- Author CMC analytical sections in regulatory filings.
Requirements:
- 7+ years of experience in clinical-stage analytical development.
- PhD in analytical chemistry or related field (or equivalent experience).
- Expertise in small molecule therapeutics and oral therapies
- Understanding of regulatory expectations (IND/IMPD through NDA/MAA).
- Experience managing analytical method development at 3rd party vendors.
- Strong communication and organizational skills.
- Ability to work in a fast-paced environment and travel 5-10%.
Benefits:
- Comprehensive benefits package including medical, dental, vision, LTD, time off, retirement plan, and stock options.
- Opportunity to make a difference in autoimmune and inflammatory diseases.
If you need any further assistance or have specific questions about the job, please feel free to ask!
