Senior Director, Analytical Development

Generate:Biomedicines; Somerville (MA); On-site; USD 260,000 - 380,000; Full time

Job summary

Generate:Biomedicines is seeking a Senior Director, Analytical Development to set strategic direction for analytical development of biologics in a lean, fully virtual model. The leader will drive analytical strategy, method lifecycle management, release and stability testing, comparability, and CDMO collaboration, reporting to the VP of Technical Operations.

The role oversees a small senior team and partners with QA, Regulatory, and CMC to ensure inspection readiness and regulatory submissions.

Qualifications

• Ph.D. in Biochemistry, Analytical Chemistry, or related field with 15+ years of industry experience, or M.S. with significant equivalent experience.
• Deep expertise in analytical development and QC for biologics including antibodies and fusion proteins.
• Experience leading analytical strategy from candidate through commercialization readiness.

Responsibilities

• Define long-term analytical development strategy and external partner network for biologics portfolio.
• Lead development and execution of analytical strategies for protein therapeutics through late-stage development.
• Establish phase-appropriate analytical control strategies including method development, qualification, validation, and stability programs.
• Serve as senior analytical partner to cross‑functional teams (CMC, Process Development, MS&T, Quality, Regulatory).
• Build and lead a high-performing analytical organization and manage external partner performance.

Skills

Analytical development

Quality control

GMP compliance

Leadership

External partnerships

Education

Ph.D. in Biochemistry/Analytical Chemistry or related

M.S. with extensive experience

Tools

HPLC/LC-MS

Job description

Generate:Biomedicines is seeking a Senior Director, Analytical Development to set the strategic direction and lead execution of analytical development for biologics programs in a lean, fully virtual development and manufacturing model. Reporting to the Vice President, Technical Operations, this leader will shape the future analytical operating model for Generate’s biologics portfolio, including analytical strategy, method lifecycle management, release and stability testing, specifications, comparability, external analytical operations, GMP readiness, and commercialization preparation across CDMO and contract testing partners.

This leader will manage and develop a small senior team that includes leaders for Analytical Development and external testing operations, while remaining deeply engaged in critical-path execution. In Generate’s lean model, this means rolling up their sleeves and providing hands‑on leadership for high-impact technical decisions, partnering with the QA team to review batch-related analytical data and GMP documentation, support investigations, deviations, OOS/OOT events, CAPAs, change controls, health authority responses, and inspection readiness.

The Senior Director will serve as the senior analytical 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.

Here’s how you will contribute:

• Define the long‑term analytical development 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 external testingstrategies 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 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 while fostering a culture of scientific rigor, accountability, collaboration, and quality.
• Serve as Generate’s senior analytical representative with CDMOs, contract testing laboratories, and external technical partners, ensuring partner strategies, performance, and issue resolution to 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 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 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.

Leadership Responsibilities:

• 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.
• Foster strong cross‑functional collaboration across Technical Operations, CMC, Process Development, MS&T, Quality Assurance, Regulatory Affairs, Supply Chain, and external partners.
• Encourage calculated risk‑taking, continuous improvement, and scientific innovation while maintaining strong compliance, inspection readiness, and patient‑first decision‑making.

The Ideal Candidate will have:

• 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.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Compensation:

The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.