Remote Senior Scientist, Formulation & Process Leadership

Celcuity Inc.; Northern (KY); Hybrid; USD 150,000 - 175,000; Full time

Benefits offered by this job

Annual incentive bonus

Equity package

Medical/dental/vision insurance

401(k) match

PTO and paid holidays

Job summary

Celcuity Inc. is seeking a Senior/Principal Scientist in Formulation and Process Development. This remote role leads development of novel and existing formulations, spanning pre-formulation to manufacturing scale-up, with emphasis on poorly water-soluble APIs.

You will guide outsourced experiments, collaborate cross-functionally, and contribute to IP and regulatory filings. The role reports to the Director, Pharmaceutical Development and offers an annual bonus and equity package, with

Qualifications

• Ph.D./M.S./B.S. in Pharmaceutical Science, Chemical Engineering, Chemistry, Biochemistry, Biochemical Engineering, or related fields.
• 7+ years of experience in pharmaceutical development (theoretical, industry experience varies by degree).
• Demonstrated experience with formulation development and drug product development, preferably for small molecule drugs.
• Deep understanding of formulation techniques for sterile, parenteral dosage forms; other dosage forms are beneficial.
• Experience with drug-device combination products, including prefilled syringes and autoinjectors, is preferred.
• Expertise in poorly water-soluble APIs and related formulation approaches (nano-milling, nanosuspensions, salt formation, complexation).
• Experience with physicochemical characterization methods for drug substances and drug products.
• Strong communication skills with ability to interact across levels and functions.
• Excellent organizational skills and ability to prioritize multiple projects.

Responsibilities

• Lead formulation and process development projects across product lifecycle, including scale-up.
• Design, run, and interpret experiments at contract labs and CDMOs.
• Identify contract organizations to support development.
• Define and execute formulation lifecycle project plans.
• Support writing of IP and regulatory documentation.
• Maintain knowledge of formulation development trends and technologies.
• Act as SME for formulation development within the Pharmaceutical Development group.
• Summarize and present data to cross-functional audiences.
• Perform other duties as assigned.

Skills

Formulation development

Drug product development

Sterile dosage forms

Parenteral delivery

Nanosuspension formulation

Lyophilization

Physicochemical characterization

Independent decision making

MS Office

Education

Ph.D./M.S./B.S. in Pharmaceutical Science or related field

Tools

MS Office

Job description

Celcuity Inc. is seeking a Senior/Principal Scientist in Formulation and Process Development. This remote role leads development of novel and existing formulations, spanning pre-formulation to manufacturing scale-up, with emphasis on poorly water-soluble APIs.

You will guide outsourced experiments, collaborate cross-functionally, and contribute to IP and regulatory filings. The role reports to the Director, Pharmaceutical Development and offers an annual bonus and equity package, with