Associate Director, Analytical Development/Quality Control

Role Summary:

The position is responsible for analytical development, analytical technology transfer and validation, and overall management of CMC activities related to external QC testing/release and stability of antibody drug conjugates and intermediates. Depending on the product phase, the Associate Director provides both guidance and active management of analytical development and QC activities in Phase 1 thru BLA and commercial production. This includes coordinating internal and 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.

This role works closely with key stakeholders including CMC, Supply Chain, Development, R&D, Clinical, Regulatory Affairs and Project Management to define the QC capabilities required to effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts.

This role is located in Waltham, MA without the possibility of being remote. Candidates must be able to relocate.

Primary Responsibilities Include: 

• Aspects of analytical development and QC of 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
• Develop, review and approve method transfer/validation protocols and validation approaches
• Support establishment of critical quality attributes, specifications, and trend stability data to establish expiry dating of DS and DP
• Advise and plan extended characterization of intermediates and drug substance to expand product understanding and impurity characterization
• Partner with 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
• Prepare and review CMC analytically focused documentation for biologic INDs and BLAs and support FDA and EMEA interactions
• 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

Education and Skills Requirements: 

• A minimum of 8 years in Analytical Development and/or Quality Control
• Bachelor’s or master’s degree in biology, biochemistry, chemistry, or similar related field required
• Knowledge of a variety of analytical techniques including SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, GC, and mass spectroscopy
• Strong quality and analytical background with experience in general, compendial and product-specific analytical tools and practices pertinent to monoclonal antibodies, small molecules, oligonucleotides and/or mab-conjugates
• Experience with managing QC external vendors
• Experience with Oligonucleotide, Mass Spectrometric Characterization or Bioanalytical assays a plus
• Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, ideally including post-approval experience, international experience, and negotiation experience with regulatory authorities
• Strong knowledge of cGMP/ICH/FDA/EU regulations
• Ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods
• Excellent interpersonal, organizational, negotiation, and communication skills; a team member than can work collaboratively with colleagues across functions
• Ability to travel (up to ~10%)

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