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

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

Job Description:

Mammoth BioSciencesOPPORTUNITYMammoth 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 RESPONSIBILITIESAssociate Director levelResponsible for the design, development, phase appropriate qualification and verification/validation of the analytical methodologies for Mammoth's pipelineIdentify opportunities to improve productivity and efficiency in projects and analytical scienceResponsible for working as an integral part of diverse teams including CDMO analytical science teamsLead the analytical science in project teams ensuring project alignment and fostering productive relationships with other core functions across the organizationEnsure data integrity and foster an environment of knowledge sharing throughout the medicine development lifecycle processEnsure compliance with regulatory standards including GMP, ICH, EMA and FDA guidelinesSupport the preparation of global regulatory submissions, scientific reports and patentsDevelop phase-appropriate quality control strategies for drug substance and drug productManage the drug substance and drug product stability study programsLead development of scientifically sound and data driven specificationsOversee analytical and QC activities at CDMOs and Contracting Testing Laboratories, including the review and approval of test records, forms, methods, protocols and reportsIdentification 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 excipientsEnsure documentation is maintained within the quality management systemExperience of various cultures, as CDMOs are global, with potential for global travelDirector levelProvide broad CMC support for internal programs from GLP tox through IND clinical programsEnsure 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 MAALead management of CMOs for process development and manufacturing of Drug Substances and Drug Products for toxicology and cGMP suppliesDevelop 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 QUALIFICATIONSMaster's Degree in a relevant scientific disciplinePrior 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 LNPExperience in management of external CDMOs for DS/DP productionStrong 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 activitiesExcellent people manager and cross-functional leader, able to lead diverse and complex teams with demonstrated successAbility to travel both domestically and internationally, as neededPREFERRED QUALIFICATIONSPrevious experience with CMC development in gene therapyPrevious 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 productsPrevious experience in small molecule and biologics manufacturing Previous experience in formulation development for complex products like lipid nanoparticlesExperience with various cultures, as CDMOs are global, with potential for global travelBENEFITSCompany-paid health/vision/dental benefitsUnlimited vacation and generous sick timeCompany-sponsored meals and snacksWellness, caregiver and ergonomics benefits401(k) with company matchingBase Salary Range: $163,500 - $220,000Actual 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. PI58ac85f8df7b-25660-34821482

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