Senior Scientist 1, Drug Product Development

Crinetics Pharmaceuticals•San Diego, CA

2d•$123,000 - $154,000•Onsite

About The Position

Crinetics Pharmaceuticals is seeking a highly skilled and motivated professional to support Drug Product Development within Technical Operations. This role combines hands-on formulation development expertise with management of drug product development programs. This position plays a critical role in the expansion of internal on-site capabilities, including in-person drug product development activities, leveraging the candidate’s experience with formulation design and working knowledge of pharmaceutical manufacturing techniques. This individual will be an integral part of the company’s effort to discover and develop small molecule therapeutics for rare endocrine disorders and endocrine-related-tumors by supporting formulation and process development. This job will report to the Director, Drug Product Development. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community. This position will be located on-site in San Diego.

Requirements

Bachelor’s degree in pharmaceutical sciences, engineering, or related field with at least 13 years 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 (e.g. 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).
Make safety recommendations and support common laboratory safety assessments such as Hazard and Operability (HAZOP) analysis and Job Safety Analysis (JSA).
Understanding of analytical chemistry techniques and data interpretation as they relate to the analysis of drug substance and drug product (HPLC, dissolution, differential scanning calorimetry, Karl Fischer, X-ray powder diffraction, scanning electron microscopy).
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, as well as effectively and accurately 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.
PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained.
Windows, MS Office (Outlook, Word, Excel, PowerPoint), MS Project.

Nice To Haves

Hands-on experience with R&D scale spray drying equipment

Responsibilities

Provide recommendations for drug product design and development based on diverse, cross-functional stakeholder input, including Target Product Profile (TPP).
Plan and execute experiments to support drug product development for new drug candidates, from preclinical through first-in-human Phase 1 (and beyond).
Utilize knowledge of scientific fundamentals to solve complex problems and develop robust, phase-appropriate formulations with consideration for 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 the 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.