Senior Director, Analytical Development and Quality Control

The Role:

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. Reporting to the Vice President Technical Operations this leader will shape the future analytical and QC operating model for Generates 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.

This leader will manage and develop a small senior team including leaders for Analytical Development and Quality Control while remaining deeply engaged in critical-path Generates lean model this means rolling up their sleeves and 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.

Heres how you will contribute:

Define the long-term analytical development and quality control strategy operating model governance structure and external partner network required to support Generates 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 Generates 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 Generates analytical capabilities and support long-term development and commercialization objectives.

Leadership Responsibilities:

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 Generates 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 Generates 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.

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.

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 Have:

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.

Who Will Love This Job:

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.

About Generate Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creationone grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation this approach aims to reduce the uncertainty time and cost associated with developing protein-based medicines.

Founded in 2018 we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

At Generate:Biomedicines we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need faster guided by our values and leadership behaviors.

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.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Companys internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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