Crinetics Pharmaceuticals is seeking a Director, Process Engineering (Drug Substance) to lead the development and manufacturing of synthetic small-molecule drug substances. In this role, you will drive process optimization, scale-up, and tech transfer activities, supporting programs from pre-clinical through commercial launch.
What You'll Do
- Plan, direct, and oversee drug substance process development from pre-clinical through validation and commercial launch.
- Oversee and advise on scale-up activities from lab to plant and scale-down activities from plant to lab.
- Evaluate, select, and actively manage external parties (CROs, CMOs, etc.), collaborating with Quality to ensure GMP compliance.
- Manage priorities and timelines while optimizing processes, incorporating Quality by Design principles.
- Prepare drug substance development and manufacturing timelines, setting clear deliverables for projects.
- Prepare and review regulatory filings (including INDs, IMPDs, and NDAs).
- Collaborate with Pharmaceutical Development team members to author technical reports, SOPs, and policies.
- Stay current on industry trends and regulatory guidance.
- Mentor direct reports and team members, providing regular feedback and coaching.
What We're Looking For
- Advanced degree (PhD/Masters) in chemical engineering or a related discipline.
- Minimum of 10 years of experience in the pharmaceutical or related industry.
- 8 years in a supervisory role.
- In-depth understanding of GMP and CMC regulatory requirements for small molecule drug substance manufacturing.
- Technical project leadership experience in early-stage and/or late-stage drug substance process development.
- Experience leading and overseeing drug substance development programs.
- Expertise in QbD principles and risk assessments (FMEA, HAZOP).
- Demonstrated track record for developing and mentoring direct reports.
- First-hand experience writing CMC documents for regulatory submissions.
- Excellent interpersonal and communication skills.
Nice to Have
- Experience utilizing unit operation modeling and process simulation tools for synthetic molecule development.
- DoE expertise.
- Prior experience leading tech transfers to domestic and international CROs/CMOs.
- API crystallization and particle engineering experience, including dry and wet milling.
Team & Environment
You will be a member of the Pharmaceutical Development team, reporting to the Senior Director, Drug Substance CMC.
Benefits & Compensation
- Compensation range: $186,000 - $232,000
- Discretionary annual target bonus
- Stock options and ESPP
- 401k match
- Top-notch health insurance plans for employees and families (medical, dental, vision, basic life)
- 20 days of PTO
- 10 paid holidays plus a winter company shutdown
Work Mode
This is an onsite position.
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, 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 other protected characteristic.
