Crinetics Pharmaceuticals, Inc
Director, Drug Substance Development
Crinetics Pharmaceuticals, Inc, California, Missouri, United States, 65018
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:
The Director, Drug Substance Development will report to the Senior Director, Drug Substance Development in the CMC (MFG) Department. The Chemistry, Manufacturing and Controls (CMC) team is highly collaborative and operates both virtually and in-person. The Director of Drug Substance will be expected to utilize a mixture of internal lab resources and a global network of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) to develop processes and manufacture drug substance for pre-clinical through commercial stage projects. The Director of Drug Substance CMC is expected to be seen as an expert in process chemistry both within Crinetics and when working with CROs/CMOs. This position will be based in San Diego.
Essential Job Functions and Responsibilities:
Build and lead a team of lab chemists to develop and optimize synthetic processes for small molecule drug substances supporting all stages of development from IND enabling studies to clinical studies to validation and commercialization.
Support and/or lead cross-functional project teams. Coordinate drug substance activities with analytical and drug product development teams within CMC. Understand and support the needs and requirements from other functional groups including toxicology, pharmacokinetics, and regulatory. Provide updates to project and management teams.
Devise and execute detailed plans for scale-up and manufacturing utilizing external CROs/CMOs.
Participate in headcount planning, budget planning and API needs forecasting (including expenditures with CROs/CMOs and consultants).
Develop departmental processes to achieve objectives, policies and procedures for immediate team/function.
Draft drug substance sections for regulatory filings (INDs, IMPDs, NDAs, briefing packages, or other regulatory dossiers).
Able to anticipate, identify, and resolve key scale-up challenges through critical evaluation of process and analytical data.
Mentor direct reports and team members (internal as well as external) assuring desired project outcomes while developing and providing opportunities for rising talent. Provide regular feedback and coaching for their professional development.
Incorporate QbD principles and novel technology to process development, as appropriate.
Other duties as assigned.
Education and Experience:
Required:
Advanced degree (PhD/Masters) in chemistry, chemical engineering, or a related discipline is required with a minimum of 10 years of experience in the pharmaceutical or other related industry. Exceptional candidates without an advanced degree may be considered.
Hands-on working experience and in-depth understanding of GMP requirements and CMC regulatory requirements for small molecule drug substance manufacturing and related quality requirements.
Technical project leadership experience in early-stage and/or late-stage drug substance process development.
Experience leading and overseeing process chemistry teams internally or externally, a minimum of 8 years in a supervisory/leadership role is required.
Demonstrated track record for developing and mentoring direct reports or junior team members.
First-hand experience in writing/assisting with CMC documents for regulatory submissions.
Excellent interpersonal and communication skills (written and oral). This includes the ability to effectively and accurately present data to peers, management, and external partners.
Preferred:
Experience with process development and characterization using QbD principles and application of risk assessment tools such as FMEA.
Strong preference will be given for candidates with DoE expertise.
Prior experience in technical management of domestic and international CROs/CMOs.
Experience working with peptide drug substances is considered a plus.
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. Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees must be able to wear respiratory protection and other personal protective equipment for certain tasks essential to the job function. Laboratory Activities:
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: $176,000 – $220,000 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. 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.
#J-18808-Ljbffr
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. Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees must be able to wear respiratory protection and other personal protective equipment for certain tasks essential to the job function. Laboratory Activities:
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: $176,000 – $220,000 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. 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.
#J-18808-Ljbffr