Senior Director, Analytical Chemistry & CMC Strategy

Celcuity; United States; On-site; USD 230,000 - 240,000; Full time

Benefits offered by this job

Annual performance bonus

Equity package

Comprehensive benefits

Job summary

Celcuity is seeking a Senior Director of Analytical Development & Operations to lead the small molecule analytical program from early development to commercial support. You will establish robust analytical methods, specifications, and stability programs at CDMOs and coordinate outsourced PK/TK assays.

You will serve as the SME for analytical development approaches and testing across APIs and drug products, driving strategy for DS/DP analytical methods and ensuring CMC sections meet IND through

Qualifications

• PhD, Master's, or Bachelor's degree in a physical science field, ideally analytical chemistry.
• ≥ 12 years in analytical chemistry of small molecule testing.
• Experience with IND-enabling development.
• API and impurity testing expertise; drug product only experience not counted.
• Direct experience supervising outsourced biological sample analysis (LC-MS/MS) in GLP/FDA/EMA guidelines.
• Expertise with LC, GC, NMR, MS, XRPD and related analytical methods.
• Familiarity with FDA, EMA, ICH guidelines for drug substance manufacturing and QA.
• Strong written and verbal communication and ability to influence across levels.

Responsibilities

• Lead analytical development and material characterization for existing and new compounds.
• Establish phase-appropriate DS/DP analytical methods strategy including solid-state characterization and impurity profiling.
• Provide expertise in analytical testing: DSC, IR, particle size, GC, MS, XRD, etc.
• Oversee external CDMO partners for development, qualification, validation, transfer of methods; troubleshoot non-conformances.
• Support formulation development and pre-clinical characterization.
• Investigate deviations, OOS results, and stability trends; act as technical authority.
• Prepare and review CMC sections and bioanalytical components for IND through NDA and ROW submissions.
• Perform other duties as assigned.

Skills

Leadership

Communication

Attention to detail

Teamwork

Decision making

Healthcare industry knowledge

Education

PhD/Masters/Bachelor in physical sciences

Tools

LC-MS/MS

LC

GC

NMR

XRPD

MS Office (Word, Excel, PowerPoint)

Job description

Celcuity is seeking a Senior Director of Analytical Development & Operations to lead the small molecule analytical program from early development to commercial support. You will establish robust analytical methods, specifications, and stability programs at CDMOs and coordinate outsourced PK/TK assays.

You will serve as the SME for analytical development approaches and testing across APIs and drug products, driving strategy for DS/DP analytical methods and ensuring CMC sections meet IND through