Senior Scientist , Drug Product Development

Position Summary

Crinetics Pharmaceuticals seeks a highly skilled professional to support Drug Product Development within Technical Operations. This role combines hands‑on formulation development expertise with management of drug product development programs, covering design and execution of experiments, technical transfer, and regulatory documentation.

• Provide recommendations for drug product design and development based on diverse cross‑functional stakeholder input, including Target Product Profile (TPP).
• Plan and execute experiments for drug product development for new drug candidates, from preclinical through Phase1 and beyond.
• Utilize scientific fundamentals to solve complex problems and develop robust, phase‑appropriate formulations, considering future technical transfer of scalable manufacturing processes.
• Support technical transfer of formulation and process to external vendors to reliably deliver clinical trial materials, including in‑person support of critical manufacturing activities.
• Interpret and analyze scientific results for presentation and make product development recommendations.
• Author drug product development technical reports and relevant sections of regulatory submissions.
• Meet current and future needs of drug product development through in‑person experimental execution in drug product development labs.
• Develop and implement lab policies, practices, and workflows to support safe, high‑quality, and efficient lab operations.
• Develop and maintain high‑quality and robust experimental data acquisition and record‑keeping practices.
• Maintain equipment to ensure safe, optimal performance and enable execution of high‑quality drug product development activities in a timely manner.
• Train other personnel in relevant areas of expertise, including lab safety practices, equipment use and cleaning, and experimental study execution, as needed.
• Other duties as assigned.

• Bachelor’s degree in pharmaceutical sciences, engineering, or related field with at least 10years of relevant technical experience (an equivalent combination of experience and education may be considered).
• Proven hands‑on experience supporting the development of oral solid dosage and first‑in‑human formulations rooted in scientific fundamentals expertise.
• Subject‑matter expertise and hands‑on knowledge of common oral solid dosage formulation/process equipment (blending, granulation, tablet compression, pan coating, etc.) and related characterization techniques.
• Hands‑on experience with R&D‑scale spray‑drying equipment strongly preferred.
• Experience managing maintenance of lab‑based equipment and instruments (including coordinating vendor‑supported maintenance and calibration).
• Ability to make safety recommendations and support common laboratory safety assessments such as HAZOP and JSA.
• Understanding of analytical chemistry techniques and data interpretation (HPLC, dissolution, DSC, Karl Fischer, X‑ray powder diffraction, SEM).
• Understanding of cGMP requirements and ICH and regulatory guidance, including ability to apply to development programs.
• Excellent oral communication skills, including the ability to explain complex concepts and present data to peers, management, and external partners.
• Excellent writing skills for preparation of experimental procedures and technical reports.
• Demonstrated ability to work in a goal‑and‑team‑oriented setting and communicate/manage competing priorities.
• Flexibility to operate within a rapidly changing environment with a safety‑first mindset and high attention to detail.

Equipment: PC, scanners, voice‑mail and e‑mail systems, common office machines, or ability to be trained. Software:
Windows, MS Office (Outlook, Word, Excel, PowerPoint), MS Project.

• Extensive drug product formulation and process laboratory experience needed and required for day‑to‑day job activities.
• On a continuous basis, sit at desk for a long period; intermittently answer telephone and write or use a keyboard for communication.
• Some walking and lifting up to 20lbs may be required.
• The noise level in the work environment is usually low to…