Associate Director/Director of Drug Product Development - Sterile Products (mRNA Therapeutics)

Company: Mammoth Biosciences
Location: Brisbane
Posted on: May 1, 2025

Job Description:

Mammoth BioSciences

OPPORTUNITYMammoth is seeking an experienced and highly motivated Director of Drug Product Development - Sterile Products (mRNA Therapeutics) to lead formulation and process development for our pipeline of mRNA-based therapeutics. This is a critical and hands-on leadership role within a start-up environment. The successful candidate will be responsible for establishing the sterile drug product development function, working cross-functionally to support early-phase development through clinical supply, and partnering with external manufacturing organizations to bring first-in-human and subsequent programs to the clinic.

KEY RESPONSIBILITIES

• Strategic & Functional Leadership:
• Serve as the drug product subject matter expert for mRNA-LNP sterile injectables, establishing internal capabilities and setting phase-appropriate development strategies
• Build the drug product development function from the ground up-designing systems, workflows, and documentation standards suitable for an early-stage company scaling for growth
• Partner closely with Process Development, Analytical, Quality, Regulatory, and Program Management to align technical and strategic plans
• Formulation & Process Development:
• Design and optimize mRNA-LNP formulations suitable for parenteral administration, with a focus on stability, manufacturability, and delivery
• Develop scalable, phase-appropriate aseptic drug product processes, including fill-finish operations, cryogenic handling (as applicable), and cold-chain compatibility
• Assess and implement suitable container-closure systems (vials, syringes) that meet regulatory and operational requirements
• CDMO Oversight & Tech Transfer:
• Lead selection and oversight of CDMO partners for fill-finish operations and drug product testing
• Drive technology transfer of processes and methods to external partners; provide technical oversight for engineering and GMP runs
• Manage timelines, budgets, and deliverables in collaboration with internal stakeholders
• Regulatory & Compliance:
• Author and review the drug product portions of regulatory submissions (INDs/CTAs), including descriptions of manufacturing, control strategies, and stability programs
• Ensure compliance with cGMP and global regulatory requirements, leveraging a risk-based, phase-appropriate approach
• Serve as SME during regulatory interactions and inspections
• Team Building & Mentorship:
• Initially operate in a hands-on, player-coach capacity with strong individual contributions
• Foster a collaborative, accountable, and mission-driven team cultureREQUIRED QUALIFICATIONS
  • Ph.D. or M.S. in Pharmaceutics, Chemical Engineering, Biochemistry, or related field with a minimum of 5 years (PhD) of sterile drug product development experience, preferably with mRNA or other advanced modalities; minimum of 7 years with a Master's degree
  • Strong working knowledge of mRNA-LNP formulation, cryogenic storage, and cold-chain management
  • Proven track record of advancing sterile injectable products into the clinic, ideally within a fast-paced or resource-constrained environment
  • Experience with fill-finish operations, aseptic processing, and external manufacturing oversight
  • Excellent problem-solving, communication, and cross-functional collaboration 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 coast
    PREFERRED QUALIFICATIONS
    • Entrepreneurial spirit and comfort operating in ambiguity; energized by building systems from the ground up
    • Experience in early-phase biotech
    • Familiarity with microfluidics-based LNP manufacturing or novel delivery platforms
      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 matchingBase Salary Range: $167,000 - $240,000 per year
        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.
        
        
        
        
        PI9554e95a7141-37248-37382290

Keywords: Mammoth Biosciences, Rancho Cordova , Associate Director/Director of Drug Product Development - Sterile Products (mRNA Therapeutics), Executive , Brisbane, California