Celcuity Inc.

Lead formulation and process development projects for novel and existing drug products throughout their lifecycle, from pre-formulation to manufacturing scale-up. Manage outsourced experiments at contract laboratories and CDMOs while serving as a subject matter expert for the broader team.

Responsible for reviewing and verifying executed batch records, analytical data, and quality control results to ensure compliant product release. The role involves managing documentation in eQMS, communicating with CMOs, and implementing QA standard operating procedures.

Provide strategic and operational leadership for clinical safety activities, including oversight of end-to-end safety operations and external vendors. Lead the authorship of aggregate safety reports and ensure compliant safety oversight across clinical trials.

Responsible for medical oversight of drug safety and pharmacovigilance activities, including medical triage, signal detection, and risk management for marketed and developmental products. The role involves managing safety vendors, ensuring regulatory compliance, and preparing aggregate safety reports and agency queries.