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Associate Director / Director, CMC

Associate Director / Director, CMC

Bayside SolutionsCA, United States
30+ days ago
Salary
$166,400.00–$218,400.00 yearly
Job type
  • Full-time
  • Permanent
Job description

Associate Director / Director, CMC

Direct Hire Full-Time Role

Salary Range : $166,400 - $218,400 per year

Location : Brisbane, CA - Onsite Role

Job Summary :

As an Associate Director or Director of CMC, you will support all developmental and clinical programs, managing a network of CDMOs and partners for drug substance and drug product manufacturing across the development pipeline.

Duties and Responsibilities :

Associate Director :

  • Responsible for the design, development, phase-appropriate qualification, and validation of analytical methodologies
  • Identify opportunities to improve productivity and efficiency in projects and analytical science.
  • Work as an integral part of diverse teams, including CDMO analytical 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 substances and drug products.
  • 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.
  • Identify and develop suitable analytical methods to comprehensively characterize the quantitative and qualitative attributes of drug substance and drug product and associated impurities and excipients.
  • Ensure documentation is maintained within the quality management system.
  • Travel to CDMOs worldwide as required.

Director :

  • Provide broad CMC support for internal programs, from GLP tox to IND clinical programs.
  • Ensure timely drug substance and drug product supply for non-clinical and clinical studies.
  • Assist in preparing and reviewing 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 and late-phase drug substance and 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 relationships with internal stakeholders (e.g., Discovery, Non-Clinical, CMC, Clinical Operations, Regulatory, Quality, Finance, etc.) to deliver on goals and objectives.

    • Requirements and Qualifications :

  • Master's Degree in a relevant scientific discipline
  • Prior experience with CMC development in gene therapy
  • 10+ years experience in biotech in large and small molecules (Director); 8+ years experience (Associate Director)
  • Strong process understanding in 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 and manufacturing activities
  • An excellent manager and cross-functional leader, able to lead diverse and complex teams with demonstrated success
  • Able to travel both domestically and internationally, as needed

    • Preferred Qualifications :

  • Previous experience in CMC development of gene therapy products
  • Previous experience managing CDMOs for outsourced manufacturing
  • Extensive understanding of cGMP regulations
  • Previous experience working in small to midsize biotech
  • Previous experience in small molecule and biologics manufacturing
  • Previous experience in formulation development for complex products like lipid nanoparticles
  • Experience with various cultures for global travel

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    Desired Skills and Experience

    CMC development, gene therapy, large molecule, small molecule, biologics, oligonucleotide, cell therapy, viral vectors, gene therapy, LNP, analytical development, cGMP