Senior Scientist 1, Drug Product Pre-Formulation Development

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. 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 Scientist 1, Drug Product Development will support API form characterization from preclinical through development and manage a CMC Material Sciences Lab. This position will report to Director, Drug Product Development CMC. The Chemistry, Manufacturing and Controls (CMC) team is highly collaborative and operates with a global network of highly qualified Contract-Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs). This position will be an integral part of the company’s effort to discover and develop small molecule therapeutics for rare endocrine disorders.  This is a unique opportunity to work with a proven and well-funded drug discovery and development company in the heart of San Diego’s biotechnology community. This position will be located in San Diego.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Perform physicochemical characterization of APIs, including solubility, polymorphism, salt screening, material properties, and hygroscopicity.

• Conduct preformulation studies to assess the stability, compatibility, and processability of APIs.

• Evaluate API properties for solid-state characterization (e.g., XRD, DSC, TGA, FTIR).

• Collaborate with formulation scientists to select the most suitable API forms and excipients for product development.

• Optimize API physical and chemical properties to improve bioavailability and stability.

• Conduct forced degradation and stability studies to assess API integrity under various conditions.

• Document findings in detailed technical reports and present results to internal teams and stakeholders.

• Ensure compliance with regulatory guidelines (e.g., ICH, FDA) for API characterization and preformulation activities.

• Support the scale-up and technology transfer of selected forms of APIs from R&D to manufacturing.

• Work collaboratively with external partners for outsourced projects.

• Draft technical documents for process transfer to internal and external partners.

• Manage CMC Material Sciences lab by overseeing installation and preventive maintenance of laboratory instruments, coordinating instrument trainings, preparing user guides or best practices for instruments for internal use, and identifying needs for additional capabilities.

• Support regulatory filings (INDs, IMPDs, NDAs, briefing packages, and other regulatory dossier) as needed.

• Other duties as assigned.

Education and Experience:

Required:

• Ph.D. in pharmaceutics, pharmaceutical sciences, chemistry, or related field, with a minimum of 3 years of relevant hands-on experience in pharmaceutical, biotech laboratory, or CDMOs. (Masters with 11 years of experience or Bachelors with 13 years of experience may be considered).

• Extensive knowledge in designing and understanding form selection processes and determination of material properties of these forms. Salt and form control strategy to support material selection and delivery of API quality attributes.

• Significant and direct work experience with instruments used in pre-formulation laboratories and in analytical techniques such as HPLC/UPLC, and solid-state characterization tools, including DSC, TGA, DVS, XRPD, microscopy etc.

• Knowledge of cGMP requirements and regulatory guidance (FDA, ICH).

• Excellent written and oral communication skills, including the drafting and reviewing technical documents and the ability to effectively and accurately present data to peers, management, and external partners.

• Excellent ability to work in a goal and team-oriented setting and handle competing priorities.

• Flexibility within a rapidly changing env