Scientist I, Drug Product

The Opportunity:

The successful candidate will contribute to formulation and process development activities from early-stage through late-stage clinical/commercial development, working closely with cross-functional partners and CDMOs to ensure robust, scalable, and compliant drug product manufacturing processes.

Key Responsibilities:

• Contribute to drug product development activities for new chemical entities (NCEs) from early development through late-stage clinical development, with exposure to commercialization activities.

• Design and execute drug product development and manufacturing activities for solid oral dosage forms, including:

  • Preformulation and formulation development

  • Manufacturing process development

  • Process scale-up, technology transfer, and process optimization

  • Process validation and commercial manufacturing support

• Support outsourced development and GMP drug product manufacturing activities at CDMOs including manufacturing oversight and troubleshooting.

• Design and execute experiments, analyze and interpret data and present results and conclusions to project teams.

• Work independently with limited supervision to conduct appropriate research and troubleshoot technical challenges, escalating complex issues as needed.

• Author and contribute to CMC documentation for regulatory submissions (e.g., INDs, NDAs, MAAs) and internal technical reports.

• Collaborate cross-functionally within CMC team (Clinical Supply, Analytical Development/QC, Quality Assurance, Drug Substance, Regulatory Affairs, and Project Management) and at enterprise level research/clinical/commercial teams to support aligned development strategy and execution.

• Travel up to 20% to CRO/CDMO sites to support and oversee development and manufacturing operations.

Required Skills, Experience and Education:

• A degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.

• D. with 0-2 years of experience or a bachelor’s/master’s degree with appropriate experience in the pharmaceutical/biotech industry settings.

• Academic or research experience relevant to drug product development, formulation, pharmaceutical sciences, or small molecule development is preferred.

• Knowledge of solid oral dosage forms, formulation principles, and pharmaceutical manufacturing processes gained through graduate research, coursework, internships, or related training is desirable.

• Familiarity with formulation and process development concepts for small molecule drug products is preferred.

• Basic understanding of pharmaceutical development, CMC principles, and global regulatory guidelines, including ICH guidelines, is desirable.

• Exposure to working in multidisciplinary or collaborative research environments, including interactions with internal or external scientific partners, is a plus.

• Strong scientific, technical writing, communication, and problem-solving skills.

• Demonstrated ability to analyze experimental data, draw scientifically sound conclusions, and communicate results effectively.

• Ability to learn quickly, manage multiple priorities, and work effectively in a fast-paced, innovation-driven, collaborative environment.

Preferred Skills:

• Ph.D. degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.