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

KEY RESPONSIBILITIES

• Responsible for the design, development, phase appropriate qualification and verification/validation of the analytical methodologies for Mammoth's pipeline
• Identify opportunities to improve productivity and efficiency in projects and analytical science
• Responsible for working as an integral part of diverse teams including CDMO analytical science teams
• Lead the analytical science in project teams ensuring project alignment and fostering productive relationships with other core functions across the organization
• Ensure data integrity and foster an environment of knowledge sharing throughout the medicine development lifecycle process
• Ensure compliance with regulatory standards including GMP, ICH, EMA and FDA guidelines
• Support the preparation of global regulatory submissions, scientific reports and patents
• Develop phase-appropriate quality control strategies for drug substance and drug product
• Manage the drug substance and drug product stability study programs
• Lead development of scientifically sound and data driven specifications
• Oversee analytical and QC activities at CDMOs and Contracting Testing Laboratories, including the review and approval of test records, forms, methods, protocols and reports
• Identification 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 excipients
• Ensure documentation is maintained within the quality management system
• Experience of various cultures, as CDMOs are global, with potential for global travel

• Provide broad CMC support for internal programs from GLP tox through IND clinical programs
• Ensure 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 MAA
• Lead management of CMOs for process development and manufacturing of Drug Substances and Drug Products for toxicology and cGMP supplies
• Develop 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 objectives

REQUIRED 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

PREFERRED QUALIFICATIONS

• Previous experience with CMC development in gene therapy
• Previous 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 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

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

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