Associate Director / Director - CMC (Chemistry, Manufacturing, and Controls)

Company: Mammoth Biosciences
Location: Brisbane
Posted on: November 1, 2024

Job Description:

Mammoth BioSciences

OPPORTUNITYMammoth Biosciences is hiring a(n) Associate Director / Director, CMC to be a key player in our product development teams, providing support across all developmental and clinical programs. The successful candidate will be involved in managing a network of CDMOs for Drug substance and Drug Product manufacturing for Mammoth's pipeline.

KEY RESPONSIBILITIES

• 
  Associate Director level
  • Responsible for the design, development, phase appropriate qualification and verification/validation of the analytical methodologies for Mammoth's pipeline
  • Identify opportunities to improve productivity and efficiency in projects and analytical science
  • Responsible for working as an integral part of diverse teams including CDMO analytical science teams
  • Lead the analytical science in project teams ensuring project alignment and fostering productive relationships with other core functions across the organization
  • Ensure data integrity and foster an environment of knowledge sharing throughout the medicine development lifecycle process
  • Ensure compliance with regulatory standards including GMP, ICH, EMA and FDA guidelines
  • Support the preparation of global regulatory submissions, scientific reports and patents
  • Develop phase-appropriate quality control strategies for drug substance and drug product
  • Manage the drug substance and drug product stability study programs
  • Lead development of scientifically sound and data driven specifications
  • Oversee analytical and QC activities at CDMOs and Contracting Testing Laboratories, including the review and approval of test records, forms, methods, protocols and reports
  • Identification and development of suitable analytical methods to allow comprehensive characterization of both the quantitative and qualitative attributes of drug substance and drug product, associated impurities and excipients
  • Ensure documentation is maintained within the quality management system
  • Experience of various cultures, as CDMOs are global, with potential for global travel
    Director level
    • Provide broad CMC support for internal programs from GLP tox through IND clinical programs
    • Ensure timely Drug Substance/Drug Product supply for non-clinical and clinical studies
    • Assist in the preparation and review of CMC sections of regulatory submissions, including IND, BLA, NDA, and MAA
    • Lead management of CMOs for process development and manufacturing of Drug Substances and Drug Products for toxicology and cGMP supplies
    • Develop and execute CMC strategies for early phase as well as late phase Drug Substance/Drug Product clinical supplies
    • Responsible for phase appropriate development and practical implementation of processes and controls for regulatory materials, intermediates, and drug substances and drug products
    • Coordinate with internal and external analytical/quality control, quality assurance, and regulatory team members to resolve technical issues or deviations during cGMP production
    • Create and manage contracts, requests for pricing, supply agreements, etc., related to drug substance and drug product manufacturing
    • Ensure activities are executed in alignment with established Quality Agreements. Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings as needed
    • Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and suppliers
    • Develop and maintain collaborative relationships with internal stakeholders (e.g., Discovery, Non-Clinical, CMC, Clinical Operations, Regulatory, Quality, Finance, etc.) to deliver on internal goals and objectivesREQUIRED QUALIFICATIONS
      • Master's Degree in a relevant scientific discipline
      • Prior experience with CMC development in Gene therapy is highly desired
      • Minimum of 10 years experience in biotech in large and small molecules (Director); minimum of 8 years experience (Associate Director)
      • Strong process understanding in one or some of: biologics, oligonucleotide, cell therapy, viral vectors, gene therapy or LNP
      • Experience in management of external CDMOs for DS/DP production
      • Strong understand of phase appropriate analytical development and manufacturing strategies for large and small molecules
      • Experience with US and EU CMC regulatory expectations, technical transfers, and complex development & manufacturing activities
      • Excellent people manager and cross-functional leader, able to lead diverse and complex teams with demonstrated success
      • Ability to travel both domestically and internationally, as neededPREFERRED QUALIFICATIONS
        • Previous experience with CMC development in gene therapy
        • Previous experience managing CDMOs for outsourced manufacturing
        • Extensive understanding of of cGMP regulations
        • Previous experience working in small to midsize biotech
        • Previous experience in CMC development of Gene Therapy products
        • Previous experience in small molecule and biologics manufacturing
        • Previous experience in formulation development for complex products like lipid nanoparticles
        • Experience with various cultures, as CDMOs are global, with potential for global travelBENEFITS
          • 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: $163,500 - $220,000
            Actual 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.
            
            
            
            
            PI516644b098bd-37248-34821482

Keywords: Mammoth Biosciences, Pleasanton , Associate Director / Director - CMC (Chemistry, Manufacturing, and Controls), Executive , Brisbane, California