Director, Analytical Development/Quality Control (QC)

Role Summary:

Dyne is seeking a Director, Analytical Development/Quality Control (QC). The Director, Analytical Development/Quality Control (QC), will be responsible for analytical development, analytical technology transfer and validation, and overall management of Chemistry, Manufacturing and Control (CMC) activities related to external QC testing/release and stability of antibody drug conjugates and intermediates. Provide both guidance and active management of analytical development and QC activities in Phase 1 thru BLA and commercial production, including coordinating external activities related to analytical method development and QC activities with contract development and manufacturing organizations (CDMOs), contract test labs (CTLs) and other external suppliers. The specific duties include:

• Responsible for all aspects of analytical development and QC of all intermediates, drug substance, and drug product including analytical development, validation, characterization, tech transfer, analytical method qualification, specifications, release, and stability testing.
• Assist with developing the analytical/QC strategy for complex biologics/bioconjugates guided by ICH frameworks.
• Partner to identify and direct external cGMP laboratories conducting raw materials, intermediate and DS/DP product testing.
• Develop, review, and approve method transfer/validation protocols.
• Perform data analysis and generate reports supporting product release and stability programs.
• Support establishment of critical quality attributes, specifications, and trend stability data to establish expiry dating of DS and DP.
• Help define product analytical validation approaches.
• Partner with Quality Assurance (QA) to provide oversight of cGMP QC-related activities and documents (change controls, deviations, CAPAs, procedures, QC raw data review, batch release support, stability protocols and programs, validation protocols, etc.).
• Oversee Reference Standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate.
• Work closely with Research and Development to support analytical development activities and enhance the tech transfer process.
• Support QA compliance with cGMPs, cGLPs and guidance for clinical trial materials.
• Prepare and review CMC analytically focused documentation for biologic INDs and BLAs and support FDA and EMEA interactions.
• Support the development of regulatory CMC documentation and partner due diligence.
• Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed, and closed within target timeframes.
• Supervise one-two junior employees.
• Up to 30% travel to external vendors both domestically (27%) and internationally (3%) (no more than 30 days at a single location in a year)

Education & Experience Requirements

• Master’s (or higher) in Biochemistry, Chemistry, Pharmaceutical Sciences or closely related
• 8 years performing QC and Analytical Method Development, including:
  • 8 years in general, compendial and product-specific analytical tools and practices pertinent to monoclonal antibodies, small molecules, and their mab-conjugates (ADCs)
  • 5 years authoring regulatory filings and providing technical support for responses to regulatory bodies
  • 5 years overseeing and managing QC external vendors for development, release and stability testing

Other Requirements:

• Demonstrated proficiency in:
  • Processes and systems to support analytical development and QC activities for Phase 1 to late -stage BLA enabling studies
  • Biologics and small molecules analytical development, quality control, and QA compliance of analytical methods
  • Supporting all clinical phases of CMC regulatory submissions and interactions regarding CMC issues

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