Director, Analytical Development

Crinetics Pharmaceuticals • San Diego, CA

90d • $182,000 - $227,000

About The Position

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.

Requirements

• Bachelor’s degree in Analytical Chemistry or related field with 12+ years of progressively responsible experience in analytical development in biopharmaceutical development, or an advanced degree (MS or PhD) with a minimum of 10 years of relevant technical and industry experience.
• 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 is desired.
• 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.

Responsibilities

• Establish, direct, and monitor implementation of appropriate Tech Ops 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/Tech Ops.
• 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 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 Tech Ops 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.).
• 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/Tech Ops 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.

Benefits

• Discretionary annual target bonus.
• Stock options.
• Employee Stock Purchase Plan (ESPP).
• 401k match.
• 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.
• Winter company shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees