KEY 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
REQUIRED QUALIFICATIONS
- 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%)
PREFERRED QUALIFICATIONS
- 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
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
Top Skills
What We Do
Mammoth Biosciences is harnessing the diversity of nature to power the next-generation of CRISPR products. Through the discovery and development of novel CRISPR systems, the company is enabling the full potential of its platform to improve lives by reading and writing the code of life. Mammoth aims to democratize disease detection with an easy and affordable point-of-care test that allows real-time and simultaneous detection of multiple conditions. By leveraging its internal research and development and exclusive licensing to Cas12, Cas13, Cas14, and CasΦ, Mammoth can provide enhanced diagnostics and genome editing for life science research, healthcare, agriculture, biodefense and more. Based in San Francisco, Mammoth Biosciences is co-founded by CRISPR pioneer Jennifer Doudna and principal founders Trevor Martin, Janice Chen, and Lucas Harrington. The firm is backed by top institutional investors including Mayfield, NFX, and 8VC, Decheng and leading individual investors including Brook Byers, Tim Cook, and Jeff Huber.

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