Senior Director, Analytical Development and Quality Control

Generate Biomedicines•Somerville, MA

19h•$210,000 - $300,000•Remote

About The Position

Generate:Biomedicines is seeking a Senior Director, Analytical Development & Quality Control to set the strategic direction and lead execution of analytical development and quality control for biologics programs in a lean, fully virtual development and manufacturing model. This leader will shape the future analytical and QC operating model for Generate’s biologics portfolio, including analytical strategy, method lifecycle management, release and stability testing, specifications, comparability, external QC operations, GMP readiness, and commercialization preparation across CDMO and contract testing partners. The role involves managing and developing a small senior team, including leaders for Analytical Development and Quality Control, while remaining deeply engaged in critical-path execution. This means providing hands-on leadership for high-impact technical decisions, GMP documentation, batch-related analytical data, investigations, deviations, OOS/OOT events, CAPAs, change controls, health authority responses, and inspection readiness. The Senior Director will serve as the senior analytical and QC partner to CMC, Process Development, MS&T, Quality, Regulatory, Supply Chain, and external partners, ensuring protein therapeutics are supported by phase-appropriate, scientifically rigorous, inspection-ready analytical control strategies that advance key company objectives and enable late-stage development and commercialization readiness.

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 to support product development and regulatory submissions.
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 in collaboration with Process Development, MS&T, and Manufacturing organizations.
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.
A strategic, proactive leader who can anticipate risks, develop mitigation plans, and ensure analytical and QC activities remain aligned with clinical, regulatory, commercial, and company-level objectives.
A hands-on senior leader who maintains appropriate engagement in technical and GMP execution activities while effectively empowering, developing, and holding their team accountable.
Excellent collaboration, communication, and influencing skills, with a demonstrated ability to build productive relationships across functions, organizations, and external partners

Nice To Haves

A hands-on enterprise leader who is equally comfortable defining long-term analytical and QC strategy, advising executive stakeholders, and diving into critical GMP investigations, batch-related analytical data, change controls, regulatory responses, and manufacturing support activities when the work requires senior judgment.
A strategic analytical leader who enjoys building organizations, developing leaders, and influencing complex cross-functional decisions that affect portfolio and company priorities.
A scientifically rigorous problem solver who can translate analytical data into actionable development, manufacturing, regulatory, and quality strategies.
A collaborative leader who thrives in a highly outsourced environment and enjoys building strong partnerships with CDMOs, testing laboratories, and internal stakeholders.
A resilient, proactive operator who can help a lean biotech team move quickly while maintaining strong scientific, GMP, and regulatory discipline.

Responsibilities

Define the long-term analytical development and quality control strategy, operating model, governance structure, and external partner network required to support Generate’s biologics portfolio from candidate selection through commercialization readiness.
Lead the development and execution of 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 assessments, stability programs, and reference standard management.
Serve as a senior enterprise leader for analytical and QC strategy, consulting with Technical Operations, Quality, Regulatory, CMC, and executive leadership on decisions that affect key company-level objectives.
Build and lead a high-performing analytical organization, directly managing leaders responsible for Analytical Development and Quality Control while fostering a culture of scientific rigor, accountability, collaboration, and quality.
Serve as Generate’s senior analytical and QC representative with CDMOs, contract testing laboratories, and external technical partners, ensuring partner strategies, performance, and issue resolution support program, portfolio, and company priorities.
Provide strategic, technical, and hands-on oversight of CDMOs and contract testing laboratories, ensuring timely delivery of analytical development, GMP release testing, stability testing, and lifecycle management activities.
Serve as the primary analytical and QC representative on cross-functional CMC teams, ensuring alignment of analytical activities with development, manufacturing, regulatory, and clinical supply objectives.
Partner closely with Process Development, MS&T, Quality Assurance, Regulatory Affairs, and Supply Chain teams to ensure analytical strategies support manufacturing readiness, process understanding, product quality, and lifecycle management.
Lead analytical support for technology transfers, process changes, comparability assessments, process characterization studies, and validation readiness activities.
Review and approve critical technical and GMP documentation, including analytical methods, specifications, protocols, reports, method transfer packages, validation documentation, and regulatory submission content.
Provide hands-on leadership during manufacturing campaigns and quality events, including review of batch-related analytical data, investigations, deviations, OOS/OOT results, CAPAs, and change controls.
Lead high-impact technical and GMP issue resolution, personally engaging in critical investigations, deviations, OOS/OOT events, CAPAs, change controls, batch data review, and health authority responses where senior judgment is required.
Drive inspection readiness and ensure analytical and QC activities are executed in accordance with global regulatory expectations, cGMP requirements, data integrity principles, and company quality standards.
Contribute to IND, BLA, IMPD, and other regulatory submissions by developing analytical strategies, reviewing submission content, and supporting health authority interactions and responses.
Establish and monitor key performance indicators for external partners, ensuring high-quality execution, right-first-time performance, timely issue resolution, and continuous improvement.
Manage departmental budgets, resource planning, and external spend to ensure efficient utilization of resources while maintaining scientific excellence and operational effectiveness.
Champion emerging analytical technologies, industry trends, and innovative approaches that strengthen Generate’s analytical capabilities and support long-term development and commercialization objectives.
Build systems, operating rhythms, and decision forums that promote accountability, transparency, scientific rigor, quality, and high-impact execution across Analytical Development, Quality Control, and external partners.
Recruit, develop, and retain a high-performing, diverse team with the technical depth, leadership capability, and collaborative mindset needed to support Generate’s portfolio and future growth.
Lead and coach leaders within Analytical Development and Quality Control, empowering strong decision-making while staying personally engaged in critical technical, GMP, regulatory, and partner-related escalations.
Ensure the team understands how analytical and QC work connects to Generate’s broader strategic goals, clinical supply priorities, regulatory commitments, commercialization readiness, and patient impact.
Foster strong cross-functional collaboration across Technical Operations, CMC, Process Development, MS&T, Quality Assurance, Regulatory Affairs, Supply Chain, and external partners.
Model transparent, courageous, compassionate, and data-driven communication, especially during complex technical decisions, quality events, partner escalations, regulatory interactions, and resource tradeoff discussions.
Encourage calculated risk-taking, continuous improvement, and scientific innovation while maintaining strong compliance, inspection readiness, and patient-first decision-making.