Director, CMC

Summary

Join a dynamic team at insitro as the (Senior) Director CMC to drive technical strategies and execution for pre-clinical and clinical stage pipeline development.

Requirements

• Ph.D. or Master's Degree in relevant biological/biomedical sciences
• 10+ years of Process dev, and CMC experience
• Strong understanding and experience with end to end biopharmaceutical development (upstream, downstream, formulation, analytical)
• Extensive experience with Technology transfers and oversight of GMP production through CDMOs
• Experience with IND/INDa authoring and regulatory interactions

Responsibilities

• Drive CMC development strategy for insitro's growing pipeline of therapeutic targets
• Oversee technical Process Development Development and CMC activities at external partners (Drug Substance, Drug Product, Analytical) ensuring adherence to quality and regulatory standards, product safety consistency and compliance in the development of clinical material
• Be a primary conduit between insitro and CDMO scientific teams on technical matters and strategy
• Provide oversight and support by evaluating and ensuring integration of technical process development/CMC efforts into product plans and timelines
• Provide technical expertise, problem solving and appropriate escalation on CMC matters including but not limited to, analytical development, process development, formulation development, data interpretation, shelf-life determination, quality control
• Ensure the seamless transfer of programs to selected partners
• Ensure partner establishes and uses proper design, monitoring and controls for manufacturing processes for high quality drug products

Benefits

• $205,000 - $275,000 target starting salary for successful US-based applicants
• Annual Performance Bonus Plan (based on company targets by role level and annual company performance)
• Equity Incentive Plan, subject to the terms of those plans and associated policies
• 401(k) plan with employer matching for contributions
• Excellent medical, dental, and vision coverage (insitro pays 100% of premiums for employees on our base plans), as well as mental health and well-being support
• Open, flexible vacation policy
• Paid parental leave
• Quarterly budget for books and online courses for self-development
• Support to occasionally attend professional conferences that are meaningful to your career growth and development
• New hire stipend for home office setup
• Monthly cell phone & internet stipend
• Access to free onsite baristas and cafe with daily lunch and breakfast
• Access to free onsite fitness center
• Commuter benefits