Senior Research Associate, Drug Product Development

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

📋 Description

• Assist in the development of drug product formulations from initial preclinical enabling studies through to clinical supply for First-in-Human (FIH) trials.

• Engage in hands-on laboratory execution, data analysis, and technical documentation to support formulation development for oral and/or parenteral dosage forms.

• Conduct hands-on formulation development tasks for preclinical and early clinical drug products, including FIH studies.

• Formulate and assess preparations for in vivo (PK, tox) and clinical applications.

• Perform laboratory experiments that involve formulation preparation, characterization, and stability testing.

• Keep precise and well-documented experimental records in electronic laboratory notebooks (ELNs).

• Assist with scale-up, technology transfer, and manufacturing processes for clinical supplies.

• Help in the creation of protocols, reports, and CMC documentation to facilitate regulatory submissions.

• Collaborate across functions with analytical, DMPK, toxicology, quality, and external partners/CDMOs.

• Address formulation and manufacturing challenges; suggest practical solutions.

• Ensure adherence to internal procedures and relevant GMP/GxP standards.

⛳️ Requirements

• Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline.

• A minimum of 3–5 years of experience in pharmaceutical formulation development, showcasing hands-on laboratory expertise.

• Experience in supporting preclinical and/or clinical formulation development, ideally through FIH.

• Familiarity with oral dosage forms and/or parenteral formulations.

• Knowledge of common formulation techniques and excipients.

• Strong organizational abilities and keen attention to detail.

• Excellent laboratory execution and problem-solving capabilities.

• Capacity to work independently with minimal supervision while also contributing effectively in a team setting.

• Understanding of regulatory expectations related to early-phase CMC development; experience with GMP manufacturing and/or clinical supply preparation is advantageous.

• Outstanding interpersonal skills, including strong oral/written communication and presentation abilities.

• Proficient in authoring and reviewing pertinent development reports.

• Ability to collaborate in cross-functional teams related to drug development with a cooperative mindset and a proactive, solution-oriented approach.

• Capacity to handle multiple priorities in a fast-paced environment.

🏝️ Benefits

• Health insurance plans (medical, dental, vision).

• 401k match.

• 20 days of PTO.

• 10 paid holidays.

• Winter company shutdown.

• Discretionary annual target bonus.

• Stock options.

• Employee Stock Purchase Plan (ESPP).