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:
Crinetics Pharmaceuticals is seeking a highly motivated professional for planning and executing of drug product development and manufacture for its clinical development programs, and planned commercial launch, joining its growing and dynamic Chemistry, Manufacturing and Controls (CMC) team. This position will report to the Senior Director, Drug Product CMC and will provide leadership on drug product development, process optimization, scale up and manufacture for late-stage development programs at Crinetics. The 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:
• Plan, direct and oversee activities related to drug product process optimization, scale-up, process validation and commercial launch for late-stage assets.
• Develop relationships with and actively manage external parties (CROs, CDMOs, etc.) collaborating with Quality to ensure compliance with current GXP regulations.
• Evaluate and select external parties for drug product development, manufacturing and packaging.
• Manage priorities and timelines while also creating value by devising new possibilities for IP, incorporating QbD principles where appropriate and practicing the best/most practical technologies.
• Prepare drug product development and manufacturing timelines, and set clear outcomes/deliverables for projects, staying accountable to the CMC team and executive leadership.
• Prepare request for proposal, evaluate work proposals / quotations and prepare associated budgets and forecasts for drug product- development and manufacturing expenses (including expenditures with CROs, CDMOs and consultants).
• Prepare and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers).
• Collaborate with other CMC team members to author/review value added systems/SOPs/policies.
• Provide progress updates and presentations to multi-disciplinary development teams, as necessary to senior management.
• Stay current on industry trends, practices and regulatory guidance.
Education and Experience:
Required:
• PhD/MS/BS in pharmaceutical sciences, chemical engineering, or other related discipline with a minimum 10 years’ experience with PhD or minimum 12 years’ experience with MS/BS.
• At least 8 years of supervisory experience.
• Extensive process development/ optimization, scale-up and process validation expertise, with emphasis on solid oral dosage forms
• Direct work experience in planning and managing late phase development and manufacturing activities at contract manufacturing organizations (CMOs)
• Clinical and/or commercial manufacturing experience and a good understanding of cGMP requirements
• Understanding of drug substance, and analytical chemistry as related to drug product development
• Excellent interpersonal skills, with strong oral/written communication and presentation skills
• Skilled in the preparation and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers) to enable an efficient drug development program
• Excellent risk management, problem-solving skills
• Ability to work in cross-functional teams as related to drug development
• Well versed with the latest trends and practices in process development, manufacturing, and the outsourcing industry
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
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 35% of your time
ABOUT CRINETICS:
Crinetics Pharmaceuticals Inc. (www.crinetics.com) is a rare endocrine disease and endocrine-related cancer therapeutics company. Crinetics’ benefit package includes health insurance, stock options, 401k, ESPP, paid time off, and the company provides a dog-friendly work environment.
The Anticipated Base Salary Range: $165,000-$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.
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.
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