Senior Manager, Drug Substance Development, CMC

Crinetics Pharmaceuticals

2d • 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 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.

Requirements

• 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.
• 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.

Responsibilities

• 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.

Benefits

• discretionary annual target bonus
• stock options
• ESPP
• 401k match
• health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
• 20 days of PTO
• 10 paid holidays
• winter company shutdown

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level