Senior or Principal Scientist, Formulation and Process Development

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

📋 Description

• Oversee formulation and process development initiatives throughout the product lifecycle.

• Assist with pre-formulation, selection of dosage forms, formulation development, process development, and scale-up for manufacturing.

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

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

• Develop and execute project plans for managing the formulation lifecycle.

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

• Stay updated on trends, techniques, and technologies in formulation development.

• Act as a subject matter expert in formulation development for Pharmaceutical Development and Celcuity.

• Summarize, document, and present information to subgroup, group, and cross-functional teams.

• Carry out other assigned responsibilities.

⛳️ Requirements

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

• A minimum of 7 years of experience in pharmaceutical development; preferred industry experience varies by degree: 4+ years for Ph.D., 5+ years for M.S., and 7+ years for B.S.

• Proficient in formulation development and drug product development, preferably for small molecule drugs.

• Strong knowledge of formulation techniques and considerations for sterile, parenteral dosage forms.

• Familiarity with ophthalmic or oral dosage forms is advantageous.

• Experience with drug-device combination products for injectable drugs is preferred.

• Technical expertise in formulation strategies and processes for poorly water-soluble APIs is preferred.

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

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

• Advanced proficiency in MS Office applications.

• Exceptional written and verbal communication abilities.

• Strong interpersonal, organizational, technical, analytical, and decision-making skills.

• Capable of managing multiple processes and documentation requirements.

• Ability to work independently or collaboratively within a team.

• Flexibility to adapt to evolving business and site needs.

🏝️ Benefits

• Annual performance incentive bonus.

• New hire equity package.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) match.

• PTO.

• Paid holidays.