Senior Director, Small Molecule Analytical Chemistry

Linn Products, Inc; Minneapolis (MN); On-site; USD 230,000 - 240,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

PTO

Paid holidays

Job summary

Celcuity is seeking a Senior Director to lead analytical development for its small molecule pipeline and to establish robust CMC methods with external CDMOs. You will supervise PK/TK outsourcing and ensure regulatory-ready documentation across IND through NDA stages.

The role emphasizes method development, impurity profiling, and state-of-the-art analytics in collaboration with multi-disciplinary teams, aiming for timely, compliant delivery.

Qualifications

• PhD/Master's/Bachelor's in physical science, analytical chemistry preferred.
• ≥ 12 years analytical chemistry experience with small molecules.
• IND-enabling development experience.
• API and impurity testing experience; drug product only not considered.
• Experience supervising outsourced LC-MS/MS analysis under GLP and bioanalytical guidelines.
• Familiar with FDA/EMA/ICH guidelines for drug substance manufacturing.

Responsibilities

• Lead analytical development and material characterization for existing and new compounds.
• Establish phase-appropriate strategies for DS/DP analytical methods.
• Provide expertise in DSC, IR, particle size, GC, MS, XRD analyses.
• Oversee CDMO partners for method development, transfer and validation.
• Support formulation development with impurity/degradation identification.
• Investigate deviations and OOS results; drive root-cause analyses.
• Author and review analytical CMC sections for IND through NDA and ROW submissions.
• Coordinate with cross-functional teams and regulatory bodies.

Skills

Analytical chemistry

IND-enabling development

impurity testing

GLP

MS Office

Communication

Education

PhD

Master's

Bachelor's

Tools

LC

GC

NMR

MS

XRPD

Job description

Celcuity is seeking a Senior Director to lead analytical development for its small molecule pipeline and to establish robust CMC methods with external CDMOs. You will supervise PK/TK outsourcing and ensure regulatory-ready documentation across IND through NDA stages.

The role emphasizes method development, impurity profiling, and state-of-the-art analytics in collaboration with multi-disciplinary teams, aiming for timely, compliant delivery.