Senior Research Associate
6 month contract
Overview: We are looking for a passionate and skilled professional to join our dynamic team as a Senior Research Associate. In this role, you will be responsible for preformulation, pre-clinical and clinical formulation, and process development for drug products. You will work within our collaborative Chemistry, Manufacturing and Controls (CMC) team, leveraging a global network of highly qualified Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs). This is an exciting opportunity to contribute to the discovery and development of small molecule therapeutics in a well-funded, small company environment located in the heart of San Diego’s biotech community.
Key Responsibilities:
- Plan and conduct pre-formulation studies for drug candidates, including physico-chemical characterization, compatibility, and stability assessments to facilitate formulation design for solid and liquid oral dosage forms.
- Design and execute experiments to develop scientifically sound, pre-clinical and clinical formulations and compounding procedures/manufacturing processes.
- Collaborate with cross-functional project teams to support pre-clinical studies.
- Work closely with Analytical Development to conduct or coordinate testing and stability studies of formulations.
- Maintain laboratory instruments and equipment, exploring options for capability enhancements.
- Prepare formulation study plans, development protocols, and reports, and analyze and interpret formulation development data.
- Collaborate with cross-functional CMC teams and coordinate with Discovery, Toxicology, DMPK, and in vivo Pharmacology teams.
- Present written and oral updates to supervisors and cross-functional teams regarding project status.
- Assist in preparing drug product sections for regulatory filings (INDs, IMPDs, NDAs).
Qualifications:
- Bachelor’s or Master’s degree in chemistry, biology, or a related field, with 3-5 years of hands-on experience in a pharmaceutical, biotech laboratory, or CDMOs.
- Practical experience with laboratory-scale equipment for formulation and process development of early-phase dosage forms, including solutions, suspensions, powders for reconstitution, and powders in capsules.
- Familiarity with instruments used in preformulation laboratories and analytical techniques such as HPLC/UPLC and spectrophotometry.
- Understanding of cGMP requirements and regulatory guidelines (FDA, ICH).
- Strong written and verbal communication skills, with the ability to present data effectively to peers, management, and external partners.
- Proficient writing skills for formulating study plans, protocols, and reports.
- Excellent teamwork and goal-oriented skills, with the ability to manage competing priorities.
- Adaptability to a fast-paced environment with a keen attention to detail.
- Strong organizational skills and the ability to thrive under pressure.
- Intermediate to advanced proficiency in software applications (e.g., Microsoft Excel, PowerPoint, MS Project); experience with Empower software is a plus
