Insitro is looking for a Director to lead our Integrated BioAnalytical Team (iBAT). You will manage a team of professionals while building internal capabilities and expanding our external vendor networks.

The iBAT team will focus on developing bioanalytical methods and CMC analytical techniques for characterizing raw materials for drug substances. The team will also guide therapeutic programs through all stages, from preclinical to clinical. Key responsibilities will include supporting development studies such as comparability assessments, process development, stability testing, and product characterization.

You have extensive hands-on experience in bioanalytical method development, qualification, and validation oversight, as well as non-regulated sample analysis to support nGLP studies. A solid understanding of phase-appropriate method development and qualification for drug substances and drug products is necessary.

You will report to the Vice President of External R&D and Bioanalysis and based in our South San Francisco office, with a hybrid approach of at least 3 days per week in the office.

Responsibilities

• Establish the team by recruiting scientific staff and setting up laboratory operations.
• Lead Bioanalytical Method Development and Fit For Purpose Qualification in house for nGLP studies.
• Engage with and guide CRO partners for supporting method validation and ensure that sample analysis and relevant reports are rigorous and on time.
• Provide technical leadership in formulation and analytical development for various modalities, including oligonucleotide drugs, biologics, and small molecules.
• Collaborate with external vendors to apply phase-appropriate methods for raw materials, drug substances, and drug products.
• Develop and implement initial methods in-house for purposes such as release assays, stability testing, and product characterization.
• Serve as the analytical lead for CMC project teams.
• Oversee troubleshooting, technology transfer (both internally and with CRO/CDMO partners), and phase-appropriate GMP validation of analytical methods.
• Work with the quality function to ensure appropriate methods and SOPs are in place for studies.
• Author and review technical reports and regulatory submissions.
• Prior experience in IND filing (Module 3 for CMC) is required.
• Promote a culture of safety, data integrity, collaboration, innovation, continuous improvement, and accountability within the team.
• Provide leadership and mentorship to junior team members.

About You

• Ph.D. in Analytical Chemistry, Biochemistry, or a related field with a preferred 8+ years of relevant industry experience.
• M.S. + 12 years of relevant industry experience can also be considered.
• Demonstrated experience managing a team of scientists and associates in a biotechnology setting.
• Proven track record in developing analytical methods for lead molecules, troubleshooting, and optimizing assays for GMP use according to ICH guidance.
• Expertise in relevant regulatory guidelines.
• Experience in developing and validating bioanalytical assays
• Proficiency in techniques such as Ligand Binding Assays (ELISA, MSD etc), RT-qPCR,ddPCR and HPLC/UPLC/LC-MS.
• Experience with mass spectrometry for large molecules and oligonucleotides, a plus

Compensation & Benefits at insitro

Our target starting salary for successful US-based applicants for this role is $210,000 - $240,000. 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.