Senior Director, Analytical Development and Quality Control

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🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $210k - $300k / year

⏰ Full Time

🟠 Senior

👔 Director

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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

• Define the long-term analytical development and quality control strategy, operating model, governance structure, and external partner network for the biologics portfolio. • Lead analytical development and quality control strategies for protein therapeutics from candidate selection through late-stage clinical development and commercialization readiness. • Establish phase-appropriate analytical control strategies, including method development, qualification, validation, specifications, comparability, stability programs, and reference standard management. • Serve as senior enterprise analytical and QC leader and advise Technical Operations, Quality, Regulatory, CMC, and executive leadership. • Build and lead the analytical organization, managing leaders for Analytical Development and Quality Control. • Oversee CDMOs, contract testing laboratories, and external analytical partners. • Serve as the primary analytical and QC representative on cross-functional CMC teams. • Partner with Process Development, MS&T, Quality Assurance, Regulatory Affairs, and Supply Chain on manufacturing readiness, product quality, and lifecycle management. • Lead analytical support for technology transfers, process changes, comparability assessments, process characterization, and validation readiness. • Review and approve technical and GMP documentation, analytical methods, specifications, protocols, reports, validation documents, and regulatory submission content. • Provide hands-on leadership for manufacturing campaigns and quality events, including batch data review, investigations, deviations, OOS/OOT results, CAPAs, and change controls. • Drive inspection readiness and compliance with global regulatory expectations, cGMP, data integrity principles, and company quality standards. • Contribute to IND, BLA, IMPD, and other regulatory submissions and support health authority interactions. • Establish and monitor external-partner KPIs and continuous improvement initiatives. • Manage departmental budgets, resource planning, and external spend. • Champion emerging analytical technologies and innovative approaches. • Recruit, develop, and retain a high-performing analytical and QC team; coach leaders and foster cross-functional collaboration.

🎯 Requirements

• Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Molecular Biology, Chemical Engineering, or 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 complex protein therapeutics. • Success developing and implementing phase-appropriate analytical strategies from candidate selection through late-stage clinical development and commercialization readiness. • Extensive experience with analytical method development, qualification, transfer, validation, lifecycle management, and control strategies for biologic drug substances and products. • Strong understanding of protein characterization techniques, including chromatography, electrophoresis, spectroscopy, potency, binding, purity, size variant, charge variant, and stability-indicating methodologies. • Experience establishing specifications, comparability strategies, stability programs, and reference standard programs. • Leadership experience building, mentoring, and developing analytical and quality organizations in biotechnology or pharmaceutical environments. • 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 in an outsourced development and manufacturing model. • Strong understanding of GMP requirements, data integrity, quality systems, 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. • Track record authoring, reviewing, and defending analytical and QC content for INDs, BLAs, IMPDs, and health authority responses. • Ability to communicate complex scientific, regulatory, quality, and operational issues to executives, cross-functional stakeholders, regulatory agencies, and external partners. • Business acumen with experience managing budgets, external spend, resource planning, and prioritization across multiple programs. • Strategic, proactive, hands-on leadership with strong collaboration, communication, and influencing skills.

🏖️ Benefits

• Annual bonus eligibility • Equity compensation • Competitive benefits package