Crinetics
pharmaceutical
Sr.ResearchAssociate,DrugProductDevelopment
Neural analysis suggests this role is
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“Sr. Research Associate, Drug Product Development at Crinetics. Skills: formulation development, drug product development, laboratory execution, data analysis, technical documentation. 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”
What You'll Achieve.
deliver high quality drug products in a fast-paced development environment
Industry & Context.
problem-solving skills; troubleshoot formulation and manufacturing propose practical solutions
Travel: up to 5% of your time, Physical Activities: On a continuous basis, sit at desk for a long period of 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., Biology and chemical laboratory environment experience needed., Environmental health and safety requirements also apply.
What They're Looking For.
Must Have
3–5 years of experience in pharmaceutical formulation development, 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, organizational skills and attention to detail, laboratory execution and problem-solving skills, Ability to work under minimal supervision while contributing effectively in a team environment, 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
Nice to Have
Knowledge of regulatory expectations related to early-phase CMC, exposure to GMP manufacturing and/or clinical supply preparation is a plus
What You'll Do.
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
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
and stability testing
Maintain accurate and well-documented experimental records in electronic laboratory notebooks (ELNs)
and manufacturing activities for clinical supplies
Assist in preparation of protocols
and CMC documentation to support regulatory submissions
Troubleshoot formulation and manufacturing propose practical solutions
Ensure compliance with internal procedures and applicable GMP/GxP requirements as needed
How You'll Work.
Team & Collaboration
works closely with formulation scientists, analytical, DMPK, toxicology, and manufacturing teams; Collaborate cross-functionally with analytical, DMPK, toxicology, quality, and external partners/CDMOs; Ability to work in cross functional teams as related to drug development with a collaborative mindset
Communication Scope
oral/written communication; presentation skills
Process & Methodology
Ability to manage multiple priorities in a dynamic environment
Full Job Description
Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. **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,
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