Senior Scientist, Formulation and Process Development

Responsibilities

• Lead projects to support development of novel and existing formulations across the product lifecycle
• Design, execute, and interpret formulation and process development experiments in outsourced environments
• Identify and vet new contract organizations and CDMOs
• Define and execute project plans for formulation lifecycle management
• Support writing technical sections for intellectual property and regulatory filings
• Serve as a subject matter expert for formulation development within the Pharmaceutical Development group
• Summarize and present technical information to cross-functional audiences

Requirements

• Ph.D/M.S./B.S. in Pharmaceutical Science, Chemical Engineering, Chemistry, Biochemistry, or related fields
• 7+ years of experience in pharmaceutical development (4+ for Ph.D, 5+ for M.S., 7+ for B.S.)
• Demonstrated experience with formulation and drug product development, preferably for small molecules
• Deep understanding of sterile, parenteral dosage forms
• Experience with physicochemical characterization methods for drug substances and products
• Strong technical, analytical, and communication skills

Preferred Qualifications

• Experience with drug-device combination products (e.g., prefilled syringes, autoinjectors)
• Expertise in formulation strategies for poorly water-soluble APIs
• Knowledge of nano-milling, nanosuspension, micro/nano-emulsions, or salt screening
• Experience with lyophilization or complexation using cyclodextrins

Benefits

• Medical, dental, and vision insurance
• 401(k) match
• Annual performance incentive bonus
• New hire equity package
• Paid time off and paid holidays

About the Company

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications.