Senior Manager, Drug Substance Development, CMC

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:

Crinetics Pharmaceuticals is seeking a highly skilled and motivated professional to support Drug Product Development within Technical Operations. This role combines proven, hand-on formulation development expertise with strategic oversight of drug product development programs. This position plays a critical role in the expansion of internal, on-site capabilities, including in-person leadership of drug product development activities, leveraging the candidate’s expertise with formulation design, and deep 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 driving early-stage formulation development and supporting late-stage 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.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Design, plan, and execute formulation development strategy and experiments for new drug candidates, from preclinical through first-in-human Phase 1 (and beyond) based on diverse, cross-functional stakeholder input, including Target Product Profile (TPP).
• Utilize strong scientific fundamentals to develop robust, phase-appropriate formulations with consideration for future technical transfer of scalable manufacturing processes.
• Lead and manage 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 recommendations.
• Author drug product development reports and relevant sections of regulatory submissions.
• Meet the current and future needs of drug product development through in-person operational leadership of formulation 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 lab safety practices, equipment use and cleaning, and experimental study execution, as needed.
• Other duties as assigned.

Education and Experience:

Required:

• Bachelor’s degree in pharmaceutical sciences, engineering, or related field with at least 8 years of relevant technical experience (an equivalent combination of experience and education may be considered).
• 5 years of supervisory years of experience
• Proven hands-on experience leading the development of oral solid dosage and first-in-human formulations rooted in scientific fundamentals expertise.
• Strong mechanical aptitude/knowledge and hands-on experience with common oral solid dosage formulation/process equipment (e.g. blending, granulation,  tablet compression, pan coating, etc.) and related analytical techniques.
• Hands-on experience with R&D scale spray drying equipment strongly preferred.
• Experience maintaining lab-based equipment and instruments (including coordinating vendor supported maintenance and calibration).
• Prior working experience with common laboratory safety assessments such as Hazard and Operability (HAZOP) analysis and Job Safety Analysis (JSA).
• Working knowledge of common drug product development characterization techniques for powders and tablets.
• 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 writing skills for preparation of operating procedures and technical reports.
• Excellent oral communication skills including the ability to effectively and accurately present data to peers, management, and external partners.
• 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.

TECHNICAL KNOWLEDGE REQUIRED:

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

Physical Demands and Work Environment:

Laboratory Activities: Extensive drug product formulation and process laboratory experience needed and required for execution of day-to-day job activities. Environmental health and safety requirements also apply.

Physical Activities: On a continuous basis, sit at desk for a long period of time;

intermittently answer telephone and write or use a keyboard to communicate

through written means. Some walking and lifting up to 20 lbs. may be required. The

noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Travel:

Travel may be required up to 20% of time to observe or support vendor site activities.

Equal Opportunity Employer:

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Salary Range

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.