Senior Director, Analytical Development & QC

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. 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 robust pipeline across preclinical and clinical development. 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. Come join our team as we transform the lives of others.

Position Summary:

The Senior Director will perform analytical research and development and Quality Control functions for active pharmaceutical ingredients (API) and drug product (DP), and the Senior Director will provide direction and oversight of all activities related to the analytical methods development, qualification, and validation. The Senior Director will oversee all API and DP release stability testing as well as analytical regulatory documentation to support global clinical studies. 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.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Provide technical leadership and guidance across CMC development disciplines to all outsourced analytical methods and testing activities by providing clear objectives for multiple CDMO partners.
• Oversee the establishment of testing methodology specifications, and stability programs for raw materials, intermediates, excipients, APIs and DPs, including trend analysis, and retesting strategy for clinical trial materials.
• Manage analytical scientists and other skilled professionals and mentoring them in all matters related to drug development.
• Review and approve analytical methods, specifications, change controls, deviation, investigation, out-of-trend, or out-of-specification reports.
• Work in close collaboration and support with other members of the CMC team responsible for API and DP development and support to management as necessary.
• Support, in collaboration with Quality and Regulatory, selection of strategic CDMO, manufacturing, analytical, and packaging partners.
• Negotiate, obtain, and review for accuracy legal and corporate approval for service agreements and related statements of work for development activities with external partners.
• Lead cross-functional teams (with Quality and Regulatory) in the selection of strategic CDMO, manufacturing, analytical, and partners, initially for all stages of development.
• Develop strong relationships with external said partners to establish and manage appropriate scopes of work, and to ensure all activities are within program expectations.
• Prepare and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers).
• Create new systems/SOPs/policies and work with Quality Assurance to oversee these for compliance with current GXP regulations.
• Work with Regulatory, QA and Senior Management to ensure that all company policies are followed, and all external manufacturing activities comply with relevant regulations.
• Provide succinct and pertinent communication (oral and written) on the status of programs, CMC priorities and pending activities, across company functional areas and to senior leadership.
• Budget, manage financials, and forecast all analytical and stability related expenses.
• Build collaborative relationships across functional areas to translate research and clinical program objectives into aligned, clear, and fit-for-purpose CMC objectives and milestones.
• Supervise the building of in-house analytical development capabilities, from procurement of instrumentation to selection and design of laboratory space.
• Other duties as may be assigned.

Education and Experience:

Required:

• A PhD in analytical chemistry or related field with at least 13 years of analytical/CMC team leadership in the CDMO or pharmaceutical industry supporting small-molecule solid oral drug products, plus a minimum of 10 years in a supervisory/leadership role.
• Experience in Contract Research Organizations and/or contract laboratory relationship management.
• Extensive technical expertise in analytical development and validation for API and DP, and characterization and stability of small molecules and solid oral drug products..

• Proficiency in reviewing and analyzing release and stability data for trending, shelf-life, and specification determination Thorough understanding of phase appropriate methods qualification and/or validation and specifications for APIs and DPs.
• Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacture, and stability.
• Excellent interpersonal and communication skills (written and oral), including negotiation skills.
• Must be well organized, proactive, and detail-oriented.
• Demonstrated leadership and management skills, with prior experience collaborating with and directing the work of others on assigned projects (including both internal teams and external collaborators) in multiple CMC programs.
• Track record of successfully driving and managing programs, overcoming challenges and risks.

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 for up to 20% of your time.

The Anticipated Base Salary Range: $214,000 - $267,000

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.