Position Summary:

The Senior Research Associate, Drug Product Development, will support the development of drug product formulations from early preclinical enabling studies through clinical supply for First-in-Human (FIH) trials. This role will contribute hands-on laboratory execution, data analysis, and technical documentation in support of formulation development for oral and/or parenteral dosage forms. The position works closely with formulation scientists, analytical, DMPK, toxicology, and manufacturing teams to deliver high quality drug products in a fast-paced development environment.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

· 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 as needed.

Education and Experience:

· 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.

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:

You may be required to travel for up to 5% of your time.

Salary Range

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.