Associate Director

3 weeks ago


Brisbane, California, United States BioSpace, Inc. Full time
Job Details

Opportunity
Mammoth Biosciences is seeking a highly skilled professional to join our team as an Associate Director/Director, CMC. This individual will play a key role in our product development teams, providing support across all developmental and clinical programs. The successful candidate will be responsible for managing a network of CDMOs for drug substance and drug product manufacturing for Mammoth's pipeline.

Key Responsibilities
  • Design, develop, and qualify analytical methodologies for Mammoth's pipeline
  • Identify opportunities to improve productivity and efficiency in projects and analytical science
  • Work closely with CDMO analytical science teams to ensure seamless transitions between drug substance and drug product programs and suppliers
  • 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 the 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 of experience in biotech in large and small molecules (Director); minimum of 8 years of experience (Associate Director)
  • Strong process understanding in one or some of: biologics, oligonucleotide, cell therapy, viral vectors, gene therapy, or LNP
  • Experience in managing 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 and 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 mid-size 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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