Director, Analytical 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. 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

The Director, CMC Analytical will report to the Senior Director, Analytical Development and Quality Control. The Chemistry, Manufacturing and Controls (CMC) team is highly collaborative with a global network of highly qualified Contract-Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs). 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. 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.

Essential Job Functions And Responsibilities

These may include but are not limited to:

Establish, direct, and monitor implementation of appropriate CMC testing methodology and specifications for raw materials, intermediates, excipients, active pharmaceutical ingredients (APIs) and drug products (DPs), with focus on oral dosage

Lead analytical development activities of the assigned projects and deliver business results for CMC Analytical

Develop departmental processes to achieve department and corporate goals

Focus on immediate and short-term (<2 year) strategic planning horizon

Work closely with external CRO/CDMOs collaborators to c advance method development, qualification, transfer, and validation for API and DP for advanced programs

Provide detailed review and approval for protocols, reports, and raw data for analytical method qualification/validation, release testing, and reference materials qualification

Review and approve analytical methods, specifications, change controls, deviations, investigations, out-of-trend and/or out-of-specification reports

Ensure consistent implementation of analytical methods and product specifications at CDMOs/contract laboratories

Work in close collaboration with and supports other members of the CMC team responsible for API and DP development and support to management, as necessary

Identify, evaluate, select, and develop relationships while actively managing external parties (CROs, CMOs, RM suppliers, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets and timelines, and oversight on due diligence efforts

Author and review CMC sections of regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers)

Author and/or review departmental related Standard Operating Procedures and guidelines, technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations to ensure compliance with cGMPs and company standards

Effectively work with RA and QA on quality system to ensure up-to-date procedures, adherence, and compliance of vendors with cGXP regulations

Participate as CMC subject matter expert in quality audits

Identify and promote opportunities to streamline in-house CMC analytical development activities

Provide leadership, career management and personal development to direct reports

Recruit and develop top talent. Align team to needs of the business.

Other projects (impurity identification and characterization, etc.) as deemed appropriate

Required

Education and Experience:

• Bachelor’s or master’s degree in analytical chemistry or related field with at least 12 years of related technical experience with increasing responsibility in biopharmaceutical development for small-molecule drug products, plus a minimum of 8 years in a supervisory role
• Work experience in a biotech or pharma company (with a focus on small molecules in late phase of development) and extensive experience in oral solid dosage forms
• Experience in relationship management of Contract Research Organization and contract laboratories
• Extensive technical experience in analytical testing, method development and phase appropriate qualification/validation, characterization, and support of stability programs for small molecule API and oral DPs
• Proficient with techniques that include but are not limited to HPLC, GC, KF, IC, LC-MS, UV-Vis, XRPD, microbial
• Proficient in at least two other areas of pharmaceutical development (e.g., solid state analysis, physical characterization, drug product dissolution)
• Successful record of managing analytical activities and overcoming challenges
• Experience in reviewing and analyzing release and stability data for trending, shelf-life and specification setting
• Solid understanding of CGLP and CGMP requirements, compendia testing, ICH, FDA, and EMA guidelines with a focus on product development and manufacture, including stability requirements
• Extensive knowledge of CGMP, quality systems and industry standards and thorough understanding of requirements for products in late phase of development
• Excellent interpersonal and communication skills (written and oral). This includes the ability to effectively and accurately present data to peers, management, and external partners.
• Excellent ability to work both independently and in a matrix team environment, in a goal and team-oriented setting and handle competing priorities
• Ability and interest in mentoring and/or managing others
• Flexibility within a rapidly changing environment and high attention to detail
• Well-developed organizational skills and detail oriented
  
  

Preferred

• Ph.D. in analytical chemistry or related field with at least 10 years of related technical experience
  
  

Physical Demands And Work Environment

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 25 lbs. may be required. The noise level in the work environment is typically 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.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel

You may be required to travel up to 20%.

The Anticipated Base Salary Range: $178,000 - $223,000

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.

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.

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.

Vaccination Requirement

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.