Senior Scientist I/II - Analytical Development (CMC)
About The Position
The Senior Scientist will be responsible for managing analytical development, guiding external partners (e.g., CTLs, CDMOs), and standing up key methods in-house to support the characterization of our CRISPR cargo (ultracompact Cas enzymes and guide RNAs) and delivery platforms (e.g., AAV, LNP). This role will work cross-functionally with Formulation, Process Development, Quality, and Regulatory teams to ensure our analytical strategy aligns with our product development goals for our in vivo gene editing pipeline.
Requirements
- PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field with 3+ years of relevant industry experience; MS with 6 years of experience in a biotech/pharma setting; Scientist II: PhD + 5 years minimum experience or MS + 8 years minimum experience
- Strong working knowledge of oligo/mRNA-LNP related analytical methods. Hands-on expertise with relevant analytical techniques for gene/cell therapies or complex biologics (e.g., HPLC, LC-MS, DLS, UV, ELISA, qPCR/ddPCR, particle/aggregate characterization, and/or enzymatic assays)
- Strong understanding of ICH guidelines, phase-appropriate method validation, and regulatory expectations
- Proven track record of guiding method qualification and validation in early phase settings
- Experience managing analytical workflows at CDMO/CTLs
- Excellent problem-solving, communication, and cross-functional collaboration skills
- Ability to regularly work onsite at our Brisbane, CA location
- Ability to travel internationally as needed (<10%)
Nice To Haves
- Experience managing external analytical testing
- Experience managing an analytical team with junior scientists
- Experience in analytical development around sgRNA-mRNA LNP drug product with modular understanding of the components
Responsibilities
- Support analytical method development and implementation, both internally and via contract labs, to support the characterization, release testing, and stability of CRISPR-based drug substance and drug product
- Establish internal capabilities for select analytical assays in R&D labs, including method qualification and troubleshooting for nucleases, guide RNAs, and delivery vehicles
- Manage relationships with external testing labs (CTLs) and manufacturing partners (CDMOs) to ensure method development, validation, and transfer meet project timelines and regulatory expectations
- Draft and review protocols, reports, and method qualification and validation documentation in compliance with ICH and relevant regulatory guidelines
- Provide technical leadership on assay design and analytical strategy, ensuring methods are phase-appropriate, scalable, and tailored for novel CRISPR-based genetic medicines
- Support preparation of CMC documentation for regulatory submissions (e.g., INDs)
- Evaluate and implement emerging analytical technologies that align with ultracompact CRISPR platform and pipeline needs
- Help build and mentor a small team as the company scales
Benefits
- Company-paid health/vision/dental benefits
- Unlimited vacation and generous sick time
- Company-sponsored meals and snacks
- Wellness, caregiver and ergonomics benefits
- 401(k) with company matching
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Telecommunications
Education Level
Ph.D. or professional degree
Number of Employees
101-250 employees
