Director, CMC Analytical
Categories: CMC (MFG)
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:
We are seeking a highly motivated professional to perform analytical functions for active pharmaceutical ingredients (API) and drug product (DP), joining its growing and dynamic team. This job 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). You 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. This is a remote role with travel to sites required.
We are seeking a highly motivated professional to perform analytical functions for active pharmaceutical ingredients (API) and drug product (DP), joining its growing and dynamic team. This job 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). You 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. This is a remote role with travel to sites required.
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.
- 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 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 works with RA and QA on quality system to ensure up-to-date procedures, adherence, and compliance of vendors with cGXP regulations.
- Participates as CMC subject matter expert in quality audits.
- Identifies and promotes opportunities to streamline in-house CMC analytical development activities.
- Other projects (impurity identification and characterization, etc.) as deemed appropriate.
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 is required
- Ph.D. in analytical chemistry or related field with at least 10 years of related technical experience is preferred.
- 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 CROs 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.
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.
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%.
You may be required to travel up to 20%.
The Anticipated Base Salary Range: $165,000-$219,000
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.
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.