Senior Director, Analytical Chemistry — Small Molecule CMC Leader

Celcuity Inc.; Minneapolis, Northern (MN, KY); Hybrid; USD 230,000 - 240,000; Full time

Benefits offered by this job

Annual incentive bonus

Equity package

Medical insurance

Dental insurance

Vision insurance

401(k) match

Paid time off

Paid holidays

Job summary

Celcuity Inc. seeks a Senior Director to lead analytical development and operations for its small molecule pipeline, ensuring robust CMC methods, specifications, and stability programs across CDMOs.

The candidate will oversee outsourced PK/TK assays, author CMC sections for regulatory submissions, and support early to commercial development with strong leadership and cross-functional collaboration.

Qualifications

• PhD, Master’s, or Bachelor’s degree in physical science, ideally analytical chemistry or closely related sciences.
• ≥ 12 years in analytical chemistry of small molecule testing; biologics/large molecules excluded.
• Experience with IND-enabling development and analytical method development.

Responsibilities

• Lead analytical development and material characterization for existing and new compounds across development stages.
• Establish phase-appropriate strategies for DS/DP analytical methods and solid-state characterization.
• Provide expertise in analytical testing including DSC, IR, particle size, GC, MS, XRD, and related methods.
• Oversee external CDMO partners for method development, validation, transfer, and troubleshooting.
• Support formulation development and pre-clinical characterization.
• Author and review analytical CMC sections for IND through NDA and ROW submissions.

Skills

Analytical chemistry

Leadership

Communication skills

Team collaboration

Education

PhD, Master’s, or Bachelor’s degree in physical science

Tools

LC-MS/MS

GLP/FDA/EMA guidelines

MS Office (Word, Excel, PowerPoint)

Job description

Celcuity Inc. seeks a Senior Director to lead analytical development and operations for its small molecule pipeline, ensuring robust CMC methods, specifications, and stability programs across CDMOs.

The candidate will oversee outsourced PK/TK assays, author CMC sections for regulatory submissions, and support early to commercial development with strong leadership and cross-functional collaboration.