Senior Research Associate, Drug Product Development
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Job Description
Senior Research Associate developing drug product formulations from preclinical studies to clinical supply for FIH trials. Collaborating with teams to deliver high-quality drug products in a fast-paced environment.
Responsibilities:
- Support the development of drug product formulations from early preclinical enabling studies through clinical supply for First-in-Human (FIH) trials
- Contribute hands-on laboratory execution, data analysis, and technical documentation in support of formulation development for oral and/or parenteral dosage forms
- 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
- Assist in 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
Requirements:
- 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 with a proactive, solution-oriented approach
- Ability to manage multiple priorities in a dynamic 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
- ESPP
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