Associate Director, Analytical Lab Operations

Company Name: Crinetics Pharmaceuticals

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 for Associate Director, Analytical Lab Operations. This position plays a critical role in the expansion of internal, on-site capabilities to include the in-person leadership and oversight of analytical labs. This position will report to the Sr Director, Analytical Development and Quality Control. This role will be an integral part of the company’s effort to discover and develop therapeutics for rare endocrine disorders and endocrine-related tumors by deploying their proven hands-on experience to develop analytical methods and conduct analytical characterization in a dynamic cross-functional environment. 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:

• Participate in the design and implementation of the strategic vision for internal build of analytical capabilities to meet evolving needs of the Crinetics portfolio.
• Develop analytical methods using in-house capabilities and manage the transfer of methods to testing CROs.
• Recommend and implement improvements to laboratory operations and efficiency.
• Procure and maintain resources necessary for the execution of analytical methods in-house.
• Provide leadership, technical guidance, and training to junior laboratory staff, fostering a culture of excellence and continuous improvement.
• Conduct hands-on experimentation. Maintain high quality and robust experimental data acquisition and record keeping practices.
• Provide oversight method development, validation and transfer of analytical methods both, internally and at external CROs as needed.
• Design in-house experiments to support analytical investigations conducted both internally and externally.
• Direct laboratory operations, including prioritization of work, equipment maintenance, and quality control.
• Identify, evaluate, and introduce innovative technologies, where appropriate.
• Author operating procedures, guidelines, and reports.
• Lead design and operation of analytical labs, including selection, installation, commissioning, and operation of equipment.
• Develop and implement lab policies, practices, and workflows to support safe, high quality, and efficient lab operations.
• Work closely with Tech Operations colleagues developing analytical strategies to support early development of both drug substance and drug products.
• Present analytical lab results needed to support team decisions and program strategies.

Required

Education and Experience:

• Bachelor’s degree in chemistry, pharmaceutical sciences, or related field with at least 10 years of relevant analytical lab experience in the pharmaceutical, biotech, or CDMO sector (an equivalent combination of experience and education may be considered).
• At least 7 years of supervisory experience.
• Strong hands-on experience developing analytical methods, including stability indicating and dissolution methods.
• Understanding of analytical chemistry techniques and data interpretation as they relate to the analysis of drug substance and drug product (HPLC, dissolution, GC, LC/MS, differential scanning calorimetry, Karl Fischer, X-ray diffraction, scanning electron microscopy).
• Understanding of cGMP requirements and ICH and regulatory guidance is preferred.
• 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 operating 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 and chromatography data systems such as Empower or Chromeleon or OpenLab.

Physical Demands And Work Environment

Physical Activities: On a continuous basis, sit at a 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 accommodation may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Travel

Travel may be required up to 15% of the 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.

Total Compensation

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Salary Range

The salary range for this position is: $150,000 - $188,000.

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.