Senior Director, Analytical Development

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Define the strategic vision and oversee the implementation of analytical development for biologics programs.

• Design the analytical operational framework, encompassing analytical strategy, method lifecycle management, release and stability testing, specifications, comparability, external analytical operations, GMP readiness, and commercialization preparation.

• Lead and nurture a small senior team managing Analytical Development and external testing operations.

• Provide direct leadership for key technical decisions and quality-related events.

• Collaborate with QA on analytical data related to batches, GMP documentation, investigations, deviations, OOS/OOT events, CAPAs, change controls, health authority responses, and inspection readiness.

• Act as the primary analytical partner for CMC, Process Development, MS&T, Quality, Regulatory, Supply Chain, CDMOs, contract testing laboratories, and other external collaborators.

• Outline the long-term analytical strategy, governance, operational model, and network of external partners.

• Develop analytical control strategies, method development, qualification, validation, specifications, comparability assessments, stability programs, and management of reference standards.

• Create and lead a high-performing analytical organization.

• Oversee the performance of CDMOs and contract laboratories, including analytical development, GMP release testing, stability testing, and lifecycle management.

• Assist in technology transfers, process modifications, comparability assessments, process characterization, and validation readiness.

• Review and approve technical and GMP documentation as well as regulatory submission content.

• Ensure inspection readiness and compliance with regulatory requirements, cGMP, data integrity principles, and company quality standards.

• Contribute to IND, BLA, IMPD, and other regulatory submissions and interactions with health authorities.

• Set partner KPIs and initiate continuous improvement initiatives.

• Manage departmental budgets, resource allocation, and external expenditures.

• Advocate for emerging analytical technologies and innovative methodologies.

• Recruit, develop, mentor, and retain leaders and teams in analytical and quality fields.

⛳️ Requirements

• Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Molecular Biology, Chemical Engineering, or a related scientific field with over 15 years of relevant industry experience; alternatively, an M.S. with considerable additional relevant industry experience.

• Extensive expertise in analytical development and quality control for biologics, including monoclonal antibodies, recombinant proteins, fusion proteins, and other complex protein therapeutics.

• Proven success in developing and executing phase-appropriate analytical strategies from candidate selection through late-stage clinical development and commercialization readiness.

• Significant experience in analytical method development, qualification, transfer, validation, lifecycle management, and establishing control strategies for biological drug substances and products.

• Strong scientific knowledge of protein characterization techniques, including chromatographic, electrophoretic, spectroscopic, potency, binding, purity, size variant, charge variant, and stability-indicating methodologies.

• Demonstrated proficiency in establishing specifications, comparability strategies, stability programs, and reference standard programs.

• Proven leadership experience in building, mentoring, and developing high-performing analytical and quality teams within a matrixed biotechnology or pharmaceutical environment.

• Experience in leading leaders and cultivating senior technical talent in a lean, high-accountability organization.

• Extensive experience managing CDMOs, contract testing laboratories, and external analytical partners under a fully outsourced development and manufacturing model.

• Strong understanding of GMP requirements, data integrity principles, and quality systems, including deviations, investigations, CAPAs, change controls, OOS/OOT management, and inspection readiness.

• Experience supporting technology transfers, process characterization, manufacturing investigations, process validation readiness, and lifecycle management activities.

• Proven track record of authoring, reviewing, and defending analytical and QC content for regulatory submissions, including INDs, BLAs, IMPDs, and responses to global health authorities.

• Demonstrated capability to communicate complex scientific, regulatory, quality, and operational issues to executive leadership, senior stakeholders, regulatory agencies, and external partners.

• Strong business acumen with experience in managing budgets, external expenditures, resource planning, and prioritization across multiple programs and competing timelines.

• Strategic, proactive leadership with the ability to foresee risks, create mitigation plans, and align analytical and QC activities with clinical, regulatory, commercial, and organizational objectives.

• Hands-on senior leadership style while empowering, developing, and holding teams accountable.

• Excellent collaboration, communication, and influencing abilities.

🏝️ Benefits

• Annual bonus

• Equity compensation

• Competitive benefits package