Senior Process Chemist , Drug Substance Development

Senior Process Chemist 2, Drug Substance Development page is loaded## Senior Process Chemist 2, Drug Substance Development remote type:
Onsite locations:
San Diego, CAtime type:
Full time posted on:
Posted Yesterday job requisition :
JR000515

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.
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* Position Summary:

** The Senior Process Chemist 2, Drug Substance Development, will be responsible for designing, optimizing, and scaling synthetic chemical processes for active pharmaceutical ingredients (APIs). This role will work closely with cross-functional teams to ensure that new processes are efficient, cost-effective, safe, and compliant with regulatory standards for large-scale manufacturing. This position will report to the Director, Drug Substance Development CMC.

The Technical Operations 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:
* Develop and optimize synthetic routes for APIs from lab to pilot-plant scale.
* Collaborate with analytical chemistry and formulation teams to characterize intermediates and final products.
* Conduct risk assessments to ensure safety and environmental compliance.
* Generate process documentation, including batch records, SOPs, and technical reports.
* Explain complex scientific and technical concepts, influencing others to adopt new points of view.
* Manage daily activities of a small functional group, identifying ways to improve efficiencies and best practices within the work unit.
* Contribute to key reviewed scientific/technical documents, expert reports, or patents that enhance the company’s intellectual capital.
* Evaluate scalability and robustness of chemical processes using Design of Experiments (DoE).
* Lead technology transfer of processes to manufacturing and contract development organizations (CDMOs).
* Troubleshoot process issues and implement improvements for cost, yield, and quality.
* Stay up-to-date on regulatory requirements, including cGMP and ICH guidelines.
* Support regulatory filings (INDs, IMPDs, NDAs, briefing packages, and other regulatory dossier) as needed.
* Other duties as assigned.
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* Education and Experience:

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* Required:

* Ph.D. in organic chemistry or related field, with a minimum of 5-8 years of relevant hands-on experience in pharmaceutical, biotech laboratory, or CDMOs. (Masters with 13 years of experience or Bachelors with 15 years of experience may be considered).
* Strong background in organic synthesis, reaction mechanisms, and crystallization techniques.
* Extensive expertise in conducting chemical reactions as a process chemist, with a solid understanding of laboratory design to facilitate commercial route development.
* Familiarity with scale-up principles and pilot-plant operations.
* Knowledge of process analytical technology (PAT) and Quality by Design (QbD).
* Proficient in scientific software (e.g., Chem Draw, MATLAB, or similar).
* Significant and direct…