What are the responsibilities and job description for the Senior Scientist I/II - Analytical Development (CMC) position at BioSpace?
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
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 (
Preferred Qualifications
Actual base salary will be determined by relevant professional experience, applicable skills, and internal equity.
Mammoth Biosciences is a biotechnology company focused on leveraging its proprietary ultracompact CRISPR systems to develop long-term curative therapies, as well as other applications such as decentralized precision diagnostics. Founded by CRISPR pioneer and Nobel laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington, the company’s ultracompact proteins are designed to enable in vivo gene editing in difficult to reach tissues utilizing both nuclease applications and new editing modalities beyond double stranded breaks, including base editing, gene writing, and epigenetic editing. The company is building out its pipeline of potential in vivo gene editing therapeutics and capabilities and has partnerships with leading pharmaceutical and biotechnology companies to broaden the reach of its innovative and proprietary technology. Mammoth’s deep science and industry experience, along with a robust and differentiated intellectual property portfolio, have enabled the company to further its mission to transform the lives of patients and deliver on the full promise of CRISPR technologies.
It is our policy and intent to provide equal opportunity to all persons without regard to race, color, religion, political affiliation, sex/gender (including gender expression/identity, pregnancy, childbirth and related medical conditions), marital status, registered domestic partner status, sexual orientation, age, ancestry, national origin, veteran status, disability, medical condition, genetic characteristics, and/or any other basis protected by law. This policy covers all facets of employment including, but not limited to: recruitment, selection, placement, promotions, transfers, demotions, terminations, training, and compensation.
Mammoth Biosciences requires that all employees be vaccinated against COVID as a condition of at-will employment, with exceptions for medical or religious reasons in compliance with local, state, and federal law.
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
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
- 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
Actual base salary will be determined by relevant professional experience, applicable skills, and internal equity.
Mammoth Biosciences is a biotechnology company focused on leveraging its proprietary ultracompact CRISPR systems to develop long-term curative therapies, as well as other applications such as decentralized precision diagnostics. Founded by CRISPR pioneer and Nobel laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington, the company’s ultracompact proteins are designed to enable in vivo gene editing in difficult to reach tissues utilizing both nuclease applications and new editing modalities beyond double stranded breaks, including base editing, gene writing, and epigenetic editing. The company is building out its pipeline of potential in vivo gene editing therapeutics and capabilities and has partnerships with leading pharmaceutical and biotechnology companies to broaden the reach of its innovative and proprietary technology. Mammoth’s deep science and industry experience, along with a robust and differentiated intellectual property portfolio, have enabled the company to further its mission to transform the lives of patients and deliver on the full promise of CRISPR technologies.
It is our policy and intent to provide equal opportunity to all persons without regard to race, color, religion, political affiliation, sex/gender (including gender expression/identity, pregnancy, childbirth and related medical conditions), marital status, registered domestic partner status, sexual orientation, age, ancestry, national origin, veteran status, disability, medical condition, genetic characteristics, and/or any other basis protected by law. This policy covers all facets of employment including, but not limited to: recruitment, selection, placement, promotions, transfers, demotions, terminations, training, and compensation.
Mammoth Biosciences requires that all employees be vaccinated against COVID as a condition of at-will employment, with exceptions for medical or religious reasons in compliance with local, state, and federal law.
Salary : $150,000 - $176,000