Associate Director

3 hours ago

Brisbane, California, United States Mammoth Biosciences Full time
Job Title: Associate Director

Mammoth Biosciences is seeking an experienced Associate Director to join our team. As a key member of our product development teams, you will provide support across all developmental and clinical programs. Your expertise in managing a network of Contract Development and Manufacturing Organizations (CDMOs) for Drug substance and Drug Product manufacturing will be crucial in driving our pipeline forward.

Key Responsibilities:
  • Design, develop, and phase-appropriate qualification and verification/validation of analytical methodologies for Mammoth's pipeline
  • Identify opportunities to improve productivity and efficiency in projects and analytical science
  • Work as an integral part of diverse teams, including CDMO analytical science teams
  • Lead 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 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
  • Identify and develop 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 working with various cultures, as CDMOs are global, with potential for global travel
Requirements:
  • 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 understanding 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 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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