Analytical Sr Scientist/Associate Director

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!