Associate Director, CMC-Analytical Development
Position Summary:
The Associate Director, Analytical Development will perform analytical research and development functions for active pharmaceutical ingredients (API) and drug product (DP), joining Crinetics’ growing and dynamic team. The Associate Director will oversee analytical activities for a specific program and will author/review analytical regulatory documentation to support 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:
- Establish and direct implementation of testing methodology and specifications for raw materials, intermediates, excipients, active pharmaceutical ingredients (APIs) and drug products (DPs), with focus on oral solid and parenteral dosage forms.
- Plan and oversee work at external contract analytical labs/vendors, including method development, qualification, transfer, and validation for API and DP.
- Plan and lead in-house analytical method development for API and DP (e.g., purity and related substances, dissolution).
- Write, review, and approve protocols and reports for analytical method qualification/validation, release/stability testing, and reference materials qualification.
- Review and approve analytical methods, specifications, change controls, deviation, investigation, out-of-trend, or out-of-specification reports.
- Ensure consistent implementation of analytical methods and product specifications at vendors/contract labs.
- 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.
- Evaluate, select, and develop relationships with external parties (CROs, CMOs, RM suppliers, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets, and timelines.
- Prepare and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages and other regulatory dossiers) and updates.
- Prepare for and participate in meetings with the FDA or other regulatory bodies as needed.
- Author and/or review department related Standard Operating Procedures, analytical methods, technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations to ensure compliance with CGMPs and company standards.
- Support QA on quality systems, compliance activities, including audit functions.
- Participate in training and mentoring junior analysts.
- Manage financials for analytical activities on the specific projects.
- Stay current on industry trends, practices, and regulatory guidelines.
- Other projects (impurity, identification, etc.) as deemed appropriate.
- A Bachelor’s/Master’s degree in analytical chemistry or related field with at least 10 years of related technical experience with increasing responsibility in biopharmaceutical development work in a biotech or pharma company (with a focus on small molecules).
- Experience in oral, solid and parenteral dosage forms.
- Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.
- Extensive experience in analytical testing, method development, and phase appropriate method qualification/validation and specifications for API and DP
- Proficient with techniques that include but are not limited to HPLC, GC, KF, IC, LC-MS, dissolution, UV-Vis, XRPD, microbial burden.
- Proficient in at least one other area of pharmaceutical development (e.g., solid state analysis, physical characterization, drug product dissolution)
- Well-versed in reviewing and analyzing release and stability data for trending, shelf-life and specification determination.
- Strong Understanding of CGMP requirements, compendia testing, and ICH and regulatory guidelines including stability data requirements.
- Strong knowledge of CGMP, quality systems, and Regulatory Affairs and industry standards.
- 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 in a goal and team-oriented setting and handle competing priorities.
- Flexibility within a rapidly changing environment and high attention to detail
- Excellent project management skills.
- Well organized, proactive, and detail-oriented.
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, PowerPoint, Excel). Knowledge of other software required: iStability and GastroPlus
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 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 environments 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: $137,000-$182,000
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.