Senior Scientist I/II

4 hours ago

Brisbane CA, Australia Mammoth Biosciences Full time US$150,000 - US$176,000 per year

OPPORTUNITY 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. KEY RESPONSIBILITIESSupport 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 productEstablish internal capabilities for select analytical assays in R&D labs, including method qualification and troubleshooting for nucleases, guide RNAs, and delivery vehiclesManage relationships with external testing labs (CTLs) and manufacturing partners (CDMOs) to ensure method development, validation, and transfer meet project timelines and regulatory expectationsDraft and review protocols, reports, and method qualification and validation documentation in compliance with ICH and relevant regulatory guidelinesProvide technical leadership on assay design and analytical strategy, ensuring methods are phase-appropriate, scalable, and tailored for novel CRISPR-based genetic medicinesSupport preparation of CMC documentation for regulatory submissions (e.g., INDs)Evaluate and implement emerging analytical technologies that align with ultracompact CRISPR platform and pipeline needsHelp build and mentor a small team as the company scales REQUIRED QUALIFICATIONSPhD 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 experienceStrong 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 expectationsProven track record of guiding method qualification and validation in early phase settingsExperience managing analytical workflows at CDMO/CTLsExcellent problem-solving, communication, and cross-functional collaboration skillsAbility to regularly work onsite at our Brisbane, CA location Ability to travel internationally as needed (

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