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

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 culture

REQUIRED 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 matching

Base 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 ed