Associate Director, MSAT/External Manufacturing Management

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

Job Description:

Mammoth BioSciencesOPPORTUNITYMammoth is seeking an experienced and highly motivated Associate Director of MSAT 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 report to the Head of CMC and be responsible for global tech-transfer, documentation readiness, 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 RESPONSIBILITIESStrategic & Functional Leadership:Serve as the subject matter expert for mRNA-LNP tech transfer, establishing internal capabilities and setting phase-appropriate development strategiesBuild the MSAT function from the ground up-designing systems, workflows, and documentation standards suitable for an early-stage company scaling for growthPartner closely with Process Development, Analytical, Quality, Regulatory, and Program Management to align technical and strategic plans.Project manage external stakeholders and high profile meetings (up to 10% of time)MSAT and Alliance Management:Design and optimize mRNA-LNP formulations suitable for parenteral administration, with a focus on stability, manufacturability, and deliveryDevelop scalable, phase-appropriate aseptic drug product processes, including fill-finish operations, cryogenic handling (as applicable), and cold-chain compatibilityAssess and implement suitable container-closure systems (vials, syringes) that meet regulatory and operational requirementsCDMO Oversight & Tech Transfer:Lead selection and oversight of CDMO partners for fill-finish operations and drug product testingDrive technology transfer of processes and methods to external partners; provide technical oversight for engineering and GMP runsAccountable for batch record review and approval in accordance with regulatory guidelinesManage timelines, budgets, and deliverables in collaboration with internal stakeholdersRegulatory & Compliance:Author and review the drug product portions of regulatory submissions (INDs/CTAs), including descriptions of manufacturing, control strategies, and stability programsEnsure compliance with cGMP and global regulatory requirements, leveraging a risk-based, phase-appropriate approachServe as SME during regulatory interactions and inspectionsTeam Building & Mentorship:Initially operate in a hands-on, player-coach capacity with strong individual contributionsFoster a collaborative, accountable, and mission-driven team cultureREQUIRED QUALIFICATIONSPh.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; or 10 years with a bachelor's degreeStrong working knowledge of mRNA-LNP formulation, cryogenic storage, and cold-chain managementProven track record of advancing sterile injectable products into the clinic, ideally within a fast-paced or resource-constrained environmentExperience with fill-finish operations, aseptic processing, and external manufacturing oversightExcellent problem-solving, communication, and cross-functional collaboration skillsAbility to work onsite or commute to our Brisbane, CA location regularlyAbility to work Pacific Time Zone if not located within the west coastAbility to travel internationally as neededPREFERRED QUALIFICATIONSEntrepreneurial spirit and comfort operating in ambiguity; energized by building systems from the ground upExperience in early-phase biotech Familiarity with microfluidics-based LNP manufacturing or novel delivery platformsBENEFITSCompany-paid health/vision/dental benefitsUnlimited vacation and generous sick timeCompany-sponsored meals and snacksWellness, caregiver and ergonomics benefits401(k) with company matchingBase Salary Range: $167,000 - $209,000 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.PIcf91cbc4c0e3-25660-37762412

Keywords: Mammoth Biosciences, Union City , Associate Director, MSAT/External Manufacturing Management, Executive , Brisbane, California