Sr. Research Associate, Drug Product Development

About the role

The Senior Research Associate, Drug Product Development, supports the development of drug product formulations from early preclinical enabling studies through clinical supply for First-in-Human (FIH) trials. This role involves hands-on laboratory execution, data analysis, and technical documentation in support of formulation development for oral and/or parenteral dosage forms. Collaboration with various teams such as formulation scientists, analytical, DMPK, toxicology, and manufacturing is key.

Responsibilities

• Perform hands-on formulation development activities for preclinical and early clinical drug products, including FIH studies.
• Prepare and evaluate formulations for in vivo (PK, tox) and clinical use.
• Execute laboratory experiments including formulation preparation, characterization, and stability testing.
• Maintain accurate and well-documented experimental records in electronic laboratory notebooks (ELNs).
• Support scale-up, tech transfer, and manufacturing activities for clinical supplies.
• Aid in the preparation of protocols, reports, and CMC documentation to support regulatory submissions.
• Collaborate cross-functionally with analytical, DMPK, toxicology, quality, and external partners/CDMOs.
• Troubleshoot formulation and manufacturing challenges; propose practical solutions.
• Ensure compliance with internal procedures and applicable GMP/GxP requirements as needed.

Qualifications

• Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
• Minimum of 3–5 years of experience in pharmaceutical formulation development, with demonstrated hands-on lab experience.
• Experience supporting preclinical and/or clinical formulation development, ideally through FIH.
• Experience with oral dosage forms and/or parenteral formulations.
• Familiarity with common formulation techniques and excipients.
• Strong organizational skills and attention to detail.
• Strong laboratory execution and problem-solving skills.
• Ability to work under minimal supervision while contributing effectively in a team environment.
• Knowledge of regulatory expectations related to early-phase CMC development; exposure to GMP manufacturing and/or clinical supply preparation is a plus.
• Excellent interpersonal skills, with strong oral/written communication and presentation skills.
• Ability to author and review relevant development reports.
• Ability to work in cross-functional teams as related to drug development with a collaborative mindset and a proactive, solution-oriented approach.
• Ability to manage multiple priorities in a dynamic environment.