Senior/Principal Scientist, Formulation and Process Development

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Oversee projects that support both innovative and established formulations throughout the product lifecycle, encompassing pre-formulation, dosage form selection, formulation development, process development, and manufacturing scale-up.

• Design, implement, and analyze formulation and process development experiments in outsourced settings at contract laboratories and CDMOs.

• Identify and evaluate new contract organizations for formulation and process development.

• Assist in defining and executing project plans for formulation lifecycle management.

• Contribute to writing technical sections for intellectual property and regulatory submissions.

• Cultivate and uphold extensive knowledge of trends, techniques, and technologies in formulation development.

• Act as a subject matter expert for formulation development within the Pharmaceutical Development group and the wider Celcuity team.

• Compile, document, and deliver information to subgroup, group, and cross-functional audiences.

• Perform additional duties as assigned.

⛳️ Requirements

• Ph.D., M.S., or B.S. in Pharmaceutical Science, Chemical Engineering, Chemistry, Biochemistry, Biochemical Engineering, or related disciplines.

• 7+ years of experience in pharmaceutical development; preferred industry experience of 4+ years for Ph.D. holders, 5+ years for those with an M.S., or 7+ years for B.S. graduates.

• Proven experience in formulation development and drug product development, ideally for small molecule drugs.

• Profound understanding of formulation techniques and considerations for sterile, parenteral dosage forms.

• Familiarity with other dosage forms, such as ophthalmic or oral, is advantageous.

• Preferred experience with drug-device combination products for injectable drug formulations.

• Technical proficiency in formulation strategies and processes for poorly water-soluble APIs is highly desirable.

• Expertise in nano-milling and nanosuspension formulation, micro/nano-emulsions, salt formation and selection, complexation and co-solvency using cyclodextrins or co-solvents, or lyophilization is highly sought after.

• Experience with physicochemical characterization methods for drug substances and products.

• Background in preclinical study support and early-stage formulation development.

• Exceptional written and verbal communication skills.

• Strong interpersonal abilities.

• Meticulous attention to detail and capability to manage multiple processes and documentation requirements.

• Robust technical and analytical skills, with advanced proficiency in MS Office applications.

• Ability to collaborate effectively in a team or work independently.

• Excellent organizational and prioritization capabilities.

• Independent decision-making skills; ability to think critically in a fast-paced environment.

• Adaptable, eager to learn, and capable of adjusting to business and site demands.

• Positive, approachable, and professional demeanor.

🏝️ Benefits

• Annual performance incentive bonus.

• New hire equity package.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) match.

• PTO.

• Paid holidays.