Senior Scientist III Analytical Development (CMC)
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Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
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 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 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
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
Base Salary Range: $150000 - $176000
Actual base salary will be determined by relevant professional experience applicable skills and internal equity.
COMPANY
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 companys 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. Mammoths 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.
Required Experience:
Senior IC
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