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. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. 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 Associate Director, Process Engineering, will support mid- to late-stage manufacturing process development as part of the Manufacturing Science and Technology (MS&T) group within CMC. This job will report to the Director of MS&T and will manage activities related to drug substance and drug product process development, validation, and commercial manufacture. This individual will be an integral part of the company’s effort to develop and commercialize 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:
- Support efficient development of high quality and robust manufacturing processes using sound scientific and engineering tools to design, scale-up, characterize, and optimize manufacturing processes.
- Plan, direct, and oversee process development, manufacturing, and validation activities at contract development and manufacturing sites (CDMOs).
- Develop relationships with external parties (CROs, CDMOs, RM suppliers, consultants, etc.) and actively manage and oversee these external parties. Partner with drug substance and drug product teams to evaluate and select external parties for development and manufacturing.
- Manage priorities, timelines, and resources while also creating value by employing the best/most practical technologies, models, and simulation tools to enable efficient process characterization and optimization.
- Provide support for drug substance and drug product groups.
- Coordinate with CMC Drug Substance Development, Drug Product Development, and Analytical to build CMC timelines aligned with overall project timelines.
- Prepare development and manufacturing timelines and set clear deliverables for projects.
- Prepare and review request for proposal and statement of work, as well as associated budget.
- Provide budget, manage financials, and forecast resource expenditures, including expenditures with CDMOs and consultants.
- Evaluate relevant process and analytical data, monitor stability data, and prepare contingency plans.
- Prepare and review regulatory filings (including IBs, INDs, IMPDs, NDAs, MAAs, briefing packages, and other regulatory dossiers).
- Author and review department related Standard Operating Procedures, technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations, to ensure compliance with cGMP’s and company standards.
- Collaborate with other members of CMC (Analytical, Drug Product, Drug Substance) to develop common, value-added procedures.
- Stay current on industry trends, practices, and regulatory guidance.
- Provide presentations and updates as necessary to multi-disciplinary development teams and as necessary to management.
- Other duties as assigned.
Required
Education and Experience:
- Master’s degree in pharmacy, chemistry, chemical engineering, or related field with at least 8 years of related technical experience (an equivalent combination of experience and education may be considered).
- Lead work experience in drug substance or drug product development and clinical manufacturing for small molecules.
- Prior experience working with third parties, domestic and international, external service providers (CDMOs) desired.
- Understanding of cGMP requirements and ICH and national regulatory guidance is preferred.
- Excellent writing skills for preparation of regulatory documents and technical reports.
- Excellent oral communication skills including the ability to effectively and accurately present data to peers, management, and external partners.
- Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project); experience with DoE software is desired.
- Production experience is preferred (drug product or drug substance).
Technical Knowledge Required
- Scientific and engineering modeling and simulation tools for efficient process development.
- 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, Excel, PowerPoint). DoE software desired.
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 20 lbs. may be required. The noise level in the work environment is usually 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
Travel may be required up to 15% of your time.
The Anticipated Base Salary Range: $138,000-$192,000
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.
