We are seeking an experienced and driven Director of Analytical Development, reporting to our VP & Head of CMC. This position will lead analytical development activities and implementation of analytical strategies for our clinical-stage antibody assets. The ideal candidate will have a strong background in analytical methods development, validation, and technology transfer.

This position reports onsite a minimum of 4 days/week to our office in Boston, MA.

Responsibilities:

• Oversee and manage analytical development processes across all three of our clinical-stage antibody assets / drug candidates in support of commercialization
• Lead authoring of CMC analytical dossier and relevant sections of regulatory filings for regulatory submissions (IND, IMPD, PAS, BLA, etc.), address queries from health authorities, engage in face-to-face FDA inspection, Type-C meetings
• Develop and lead phase-appropriate analytical control strategy including establishment of quality target product profile (QTPP), assessment of critical quality attributes (CQAs), justification of specifications and establishment of test methods for antibody programs
• Accountable for method development and qualification in support of process development, product release and stability, product characterization, investigation, and process performance qualification; including improving drug substance and drug product technology transfer
• Design and oversee extended characterization studies of drug substances, drug products, and associated impurities, direct comparability strategies including assessments and stability programs
• Oversee analytical technical activities at CMO/CDMOs and contract laboratories during the process development, analytical method development, clinical batch testing, stability testing and CMC compilation of assigned projects
• Supervise product QC batch release testing of GMP drug substance and drug product lots and ensure compliance with relevant regulatory guidelines and standards
• Oversee nonGMP/GMP stability programs for all clinical-stage assets, following ICH stability requirements for setting shelf life/expiry
• Collaborate cross-functionally with internal and external teams to ensure alignment in development of processes, guidelines, strategies and timelines for analytical development
• Actively engage with leaders across the organization to drive the improvement of analytical approaches in experiment design, data analysis, documentation and reporting
• Expertly present to C-suite leadership, providing critical insights and recommendations to support company decisions

Qualifications:

• PhD with 5+ years of relevant experience, or 10+ years of experience with a Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field; equivalent advanced degrees considered
• Expert working knowledge with late-stage regulatory requirements and regulations governing the US and globally (FDA, ICH, etc.) pertaining to analytical development, including IND- and BLA-enabling regulatory writing
• Proven relevant experience in analytical development for antibody therapies (monoclonal and/or bispecific) within the biopharmaceutical/biotech industry is required
• Expertise in leading CMC projects, developing and validating analytical methods for antibodies/bispecific antibodies per ICH and regulatory guidelines
• Proven track record of successful technology transfers
• Strong knowledge of the overall biologics development and commercialization process with a proven record of applying CMC to BLA authoring to ensure execute analytical strategies approvable by health agencies
• Experience working with statistical techniques for data analysis and reporting, strong analytical skills to synthesize and analyze data effectively from various sources
• Ability to apply principles of Analytical Quality by design, including development of critical quality attributes, phase-appropriate method validation strategies, and development of an analytical control strategy in support of PPQ validation
• Working knowledge of analytical characterization techniques for biopharmaceuticals is highly desirable
• Experience maintaining effective relationships with internal and external stakeholders, including collaborations with external partners
• Demonstrated success in problem solving, task management, and effective communication in a fast-paced collaborative work environment
• Comfortable working independently and completing multiple complex project objectives simultaneously
• Experience in recruiting and leading junior analytical scientists supporting outsourced CMC programs including method development, qualification, and validation activities
• Self-motivated, organized, meticulous, flexible and eager to take on new tasks