Associate Director
2 weeks ago
OPPORTUNITY
Mammoth Biosciences is seeking a highly skilled and experienced professional to join our team as an Associate Director / Director, CMC. The successful candidate will be responsible for providing support across all developmental and clinical programs, managing a network of CDMOs for Drug substance and Drug Product manufacturing for Mammoth's pipeline.
KEY RESPONSIBILITIESAssociate Director level
Responsible 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 level
Provide broad CMC support for internal programs from GLP tox through IND clinical programsEnsure timely Drug Substance/Drug Product supply for non-clinical and clinical studiesAssist 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 suppliesResponsible for phase-appropriate development and practical implementation of processes and controls for regulatory materials, intermediates, and drug substances and drug productsCoordinate with internal and external analytical/quality control, quality assurance, and regulatory team members to resolve technical issues or deviations during cGMP productionCreate and manage contracts, requests for pricing, supply agreements, etc., related to drug substance and drug product manufacturingEnsure activities are executed in alignment with established Quality Agreements. Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings as neededWork closely with cross-functional teams to ensure seamless transitions between drug substance and drug product programs and suppliersDevelop 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 needed
- Previous experience with CMC development in gene therapy
- Previous experience managing CDMOs for outsourced manufacturing
- Extensive understanding 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 travel
- 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
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