Mammoth Biosciences
Senior Scientist I/II - Analytical Development (CMC)
Mammoth Biosciences, Brisbane, California, United States, 94005
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Mammoth BioSciences
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 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 xmvmafu 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 (
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 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 xmvmafu 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 (