Senior Scientist I/II - Analytical Development (CMC) jobs in United States
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Mammoth Biosciences · 8 hours ago

Senior Scientist I/II - Analytical Development (CMC)

Mammoth Biosciences is a biotechnology company focused on developing long-term curative therapies using ultracompact CRISPR systems. The Senior Scientist will manage analytical development, guide external partners, and establish key methods in-house to support the characterization of CRISPR cargo and delivery platforms, working cross-functionally with various teams to align analytical strategies with product development goals.

BiotechnologyGeneticsHealth DiagnosticsLife Science
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Culture & Values
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H1B Sponsor Likelynote

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

Qualification

Analytical ChemistryHPLCLC-MSRegulatory GuidelinesMRNA-LNP Analytical MethodsMethod QualificationAnalytical Workflows ManagementProblem-solvingCommunicationCross-functional Collaboration

Required

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

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

Company

Mammoth Biosciences

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Mammoth Biosciences develops novel CRISPR applications for disease detection, research, agriculture, biodefense, and more.

H1B Sponsorship

Mammoth Biosciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (7)
2023 (3)
2022 (4)
2021 (3)

Funding

Current Stage
Late Stage
Total Funding
$359.55M
Key Investors
RegeneronRedmile GroupNational Institutes of Health
2024-04-25Corporate Round· $95M
2021-09-09Series D· $150M
2020-11-04Series C· $45M

Leadership Team

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Trevor Martin
Co-Founder and CEO
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Janice Chen
Co-founder & CTO
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Company data provided by crunchbase