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Senior Scientist I/II - Analytical Development (CMC)

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Mammoth Biosciences

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Location:
United States , Brisbane

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

150000.00 - 176000.00 USD / Year
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Job Description:

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.

Job Responsibility:

  • 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

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 have:

  • 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
What we offer:
  • 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

Additional Information:

Job Posted:
December 10, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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