(Senior) Director, CMC

The Opportunity

insitro is using machine learning to yield new, clinically actionable insights into critical unmet needs for patients. We aim to “go fast and improve things” across the entire drug development process from platform to pipeline to patients and back again.

Reporting to the Chief Technical Operations Officer, the (Senior) Director CMC will drive insitro’s technical CMC strategies and execution for insitro’s multimodality pre-clinical and clinical stage pipeline. Responsibilities include driving the CMC strategy and supporting technical oversight of CDMO partners to develop, scale and manufacture clinical trial products across several modalities including oligonucleotides, small molecules and biologics for our early-stage assets and ensuring supply and regulatory success. You will be a key member of our internal program teams working with our discovery biologics, data scientists and clinical team to help drive Tx molecule selection and advancement into the clinic.

This is a remote role where you will be in our San Francisco office approximately once per month, and travel to visit external CDMO sites, as needed.

This is an excellent opportunity for a seasoned process development scientist who is passionate about using their skills and experience to accelerate the drug development process and bring better drugs to the patients who can benefit most.

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
• Provide technical support and expertise in the development, drafting and delivery of regulatory filings

About You

• Ph.D. or Master’s Degree in relevant biological/biomedical sciences
• 10+ years of Process dev, and CMC experience. Ideal candidate will have demonstrated experience with siRNA development, and additional experience in other modalities (small molecules and or biologics) is preferred.
• 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

Compensation & Benefits at insitro

Our target starting salary for successful US-based applicants for this role is $205,000 – $275,000. To determine starting pay, we consider multiple job-related factors including a candidate’s skills, education and experience, market demand, business needs, and internal parity. We may also adjust this range in the future based on market data.

This role is eligible for participation in our Annual Performance Bonus Plan (based on company targets by role level and annual company performance) and our Equity Incentive Plan, subject to the terms of those plans and associated policies.

 

In addition, insitro also provides our employees:

• 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

 

insitro is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

We believe diversity, equity, and inclusion need to be at the foundation of our culture. We work hard to bring together diverse teams–grounded in a wide range of expertise and life experiences–and work even harder to ensure those teams thrive in inclusive, growth-oriented environments supported by equitable company and team practices. All candidates can expect equitable treatment, respect, and fairness throughout the interview process.

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About insitro
 
insitro is a drug discovery and development company using machine learning (ML) and data at scale to decode biology for transformative medicines. At the core of insitro’s approach is the convergence of in-house generated multi-modal cellular data and high-content phenotypic human cohort data. We rely on these data to develop ML-driven, predictive disease models that uncover underlying biologic state and elucidate critical drivers of disease. These powerful models rely on extensive biological and computational infrastructure and allow insitro to advance novel targets and patient biomarkers, design therapeutics and inform clinical strategy. insitro is advancing a wholly owned and partnered pipeline of insights and therapeutics in neuroscience, oncology and metabolism. Since launching in 2018, insitro has raised over $700 million from top tech, biotech and crossover investors, and from collaborations with pharmaceutical partners. For more information on insitro, please visit www.insitro.com.