Senior Director, Analytical Development

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $210k - $300k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Generate Biomedicines

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

💰 $370M Series B on 2021-11

Biotechnology • Artificial Intelligence • Pharmaceuticals

Generate Biomedicines is a pioneering therapeutics company that stands at the intersection of machine learning, biological engineering, and medicine. They are leading the development of generative biology, a groundbreaking approach that uses artificial intelligence to create novel medicines with specific therapeutic functions. By studying millions of proteins, Generate Biomedicines has discovered generalizable rules by which nature encodes function, enabling them to generate medicines on demand across multiple therapeutic modalities. Their innovative platform promises to fundamentally change the way medicines are made, expanding technical possibilities and improving speed and success rates in drug discovery.

📋 Description

• Set the strategic direction and lead execution of analytical development for biologics programs • Shape the analytical operating model, including analytical strategy, method lifecycle management, release and stability testing, specifications, comparability, external analytical operations, GMP readiness, and commercialization preparation • Manage and develop a small senior team leading Analytical Development and external testing operations • Provide hands-on leadership for critical technical decisions and quality events • Partner with QA on batch-related analytical data, GMP documentation, investigations, deviations, OOS/OOT events, CAPAs, change controls, health authority responses, and inspection readiness • Serve as senior analytical partner to CMC, Process Development, MS&T, Quality, Regulatory, Supply Chain, CDMOs, contract testing laboratories, and other external partners • Define long-term analytical strategy, governance, operating model, and external partner network • Establish analytical control strategies, method development, qualification, validation, specifications, comparability assessments, stability programs, and reference standard management • Build and lead a high-performing analytical organization • Oversee CDMO and contract laboratory performance, analytical development, GMP release testing, stability testing, and lifecycle management • Support technology transfers, process changes, comparability assessments, process characterization, and validation readiness • Review and approve technical and GMP documentation and regulatory submission content • Drive inspection readiness and compliance with regulatory expectations, cGMP, data integrity principles, and company quality standards • Contribute to IND, BLA, IMPD, and other regulatory submissions and health authority interactions • Establish partner KPIs and continuous improvement initiatives • Manage departmental budgets, resource planning, and external spend • Champion emerging analytical technologies and innovative approaches • Recruit, develop, coach, and retain analytical and quality leaders and teams

🎯 Requirements

• Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Molecular Biology, Chemical Engineering, or a related scientific discipline with 15+ years of relevant industry experience; alternatively, an M.S. with significant additional relevant industry experience • Deep expertise in analytical development and quality control for biologics, including monoclonal antibodies, recombinant proteins, fusion proteins, and other complex protein therapeutics • Demonstrated success developing and implementing phase-appropriate analytical strategies from lead candidate selection through late-stage clinical development and commercialization readiness • Extensive experience with analytical method development, qualification, transfer, validation, lifecycle management, and establishment of control strategies for biologic drug substances and drug products • Strong scientific understanding of protein characterization techniques, including chromatographic, electrophoretic, spectroscopic, potency, binding, purity, size variant, charge variant, and stability-indicating methodologies • Proven experience establishing specifications, comparability strategies, stability programs, and reference standard programs • Demonstrated leadership experience building, mentoring, and developing high-performing analytical and quality organizations in a matrixed biotechnology or pharmaceutical environment • Experience leading leaders and developing senior technical talent in a lean, high-accountability organization • Significant experience managing CDMOs, contract testing laboratories, and external analytical partners within 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 authoring, reviewing, and defending analytical and QC content for regulatory submissions, including INDs, BLAs, IMPDs, and responses to global health authorities • Demonstrated ability to communicate complex scientific, regulatory, quality, and operational issues to executive leadership, senior cross-functional stakeholders, regulatory agencies, and external partners • Strong business acumen with experience managing budgets, external spend, resource planning, and prioritization across multiple programs and competing timelines • Strategic, proactive leadership with ability to anticipate risks, develop mitigation plans, and align analytical and QC activities with clinical, regulatory, commercial, and company-level objectives • Hands-on senior leadership while empowering, developing, and holding teams accountable • Excellent collaboration, communication, and influencing skills

🏖️ Benefits

• Annual bonus • Equity compensation • Competitive benefits package