Associate Director/Director, Analytical Development

Company: Mammoth Biosciences
Location: Brisbane
Posted on: May 7, 2025

Job Description:

Mammoth BioSciencesOPPORTUNITYMammoth seeks an Associate Director/Director, Analytical Development to lead and oversee all analytical development activities to support the development, characterization, and commercialization of pharmaceutical products. This includes managing method development and validation, supporting process development, ensuring product quality, and guiding regulatory strategy related to analytical controls. The individual will play a key role in setting analytical strategy, mentoring staff, managing external partnerships, and ensuring compliance with regulatory expectations.
KEY RESPONSIBILITIES

• Leadership & Strategy:
• Provide scientific and strategic leadership for analytical development across all stages of drug development
• Collaborate cross-functionally with Process Development, Formulation, Quality, Regulatory Affairs, and external partners
• Method Development & Validation:
• Oversee the development, optimization, qualification, and validation of analytical methods (e.g., HPLC, GC, LC-MS, CE, spectroscopy, cell based)
• Guide strategies for analytical control strategies including specifications and stability-indicating methods
• Product & Process Support:
• Support raw material, in-process, drug substance, and drug product testing
• Lead analytical support for process development, formulation, comparability studies, and technology transfer
• Regulatory & Compliance:
• Author, review, and approve analytical sections of regulatory filings (INDs, IMPDs, BLAs/NDAs)
• Ensure compliance with ICH, FDA, EMA, and other global regulatory guidelines
• Support audits, inspections, and quality investigations as needed
• Outsourcing & Vendor Management:
• Oversee outsourced analytical activities at CROs and CDMOs
• Manage technical transfer of methods and ensure timely and high-quality data deliveryREQUIRED QUALIFICATIONS
  • Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related discipline, with a minimum of 6 years of relevant industry experience (or equivalent combination of education and experience)
  • Demonstrated expertise in analytical method development, validation, and regulatory filings
  • Experience with both small molecule and/or biologics analytical techniques
  • Strong understanding of GMP, ICH guidelines, and regulatory expectations
  • Proven leadership and management experience, including mentoring scientific staff
  • Excellent written and verbal communication skills
  • Ability to work onsite or commute to our Brisbane, CA location regularly
  • Ability to work Pacific Time Zone if not located within the west coastPREFERRED QUALIFICATIONS
    • Experience with Gene editing modalities is highly preferred
    • Experience supporting early stage projects
    • Familiarity with QbD principles and lifecycle management of analytical methods
    • Direct experience with managing CDMOs and CROsBENEFITS
      • 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 matchingBase Salary Range: $167,000 - $240,000 per yearActual base salary will be determined by relevant professional experience, applicable skills, and internal equity. COMPANYMammoth 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. PIbb284ac0d2a0-37820-37382291

Keywords: Mammoth Biosciences, San Bruno , Associate Director/Director, Analytical Development, Executive , Brisbane, California