Associate Director, Analytical Development and Vendor Management
Sana Biotechnology, Inc.
June 24, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Associate Director, Analytical Development and Vendor Management
Responsibilities:
- Design, develop, optimize, and execute analytical assays in the laboratory to support research and translational studies across cell and gene therapy programs (~30–40%).
- Lead outsourced analytical development at CRO partners as the internal scientific owner for external assay development, qualification, and data delivery.
- Define analytical approaches and success criteria for translational questions and program milestones.
- Author and manage CRO scopes of work, technical plans, timelines, and budgets; manage performance, risks, and dependencies.
- Serve as the primary scientific interface with CROs (technical direction, troubleshooting, and decision-making).
- Ensure alignment/comparability between internal and external assays for robust data interpretation and future tech transfer.
- Review, interpret, and approve analytical data (internal and external) with scientific rigor and appropriate documentation.
- Partner with Research, Process Development, Translational Sciences, and early CMC stakeholders to align analytical outputs with program needs.
- Contribute to analytical strategy and drive continuous improvement in assay robustness, experimental design, CRO engagement, and data quality.
Qualifications:
- PhD with 5+ years; or BS/MS with 8+ years (or equivalent).
- 4+ years analytical development experience in biotech/pharma research, ideally biologics and/or cell & gene therapy.
- Hands-on molecular/biochemical methods (e.g., ddPCR, MSD, ELISA, Flow, NGS).
- Experience designing/executing assay development, qualification, and validation.
- Experience working in a GCP-compliant environment.
- Experience managing outsourced analytical work at CROs.
- Strong understanding of assay fitness-for-purpose, data quality, and comparability.
- Ability to function as individual contributor and scientific leader; excellent communication.
Preferred:
- Regulatory BioA experience (GCP, GLP).
- Clinical development and site management experience.
- Experience with fast-paced/dynamic environments.
- Experience communicating, mentoring, and leading.
Responsibilities:
- Design, develop, optimize, and execute analytical assays in the laboratory to support research and translational studies across cell and gene therapy programs (~30–40%).
- Lead outsourced analytical development at CRO partners as the internal scientific owner for external assay development, qualification, and data delivery.
- Define analytical approaches and success criteria for translational questions and program milestones.
- Author and manage CRO scopes of work, technical plans, timelines, and budgets; manage performance, risks, and dependencies.
- Serve as the primary scientific interface with CROs (technical direction, troubleshooting, and decision-making).
- Ensure alignment/comparability between internal and external assays for robust data interpretation and future tech transfer.
- Review, interpret, and approve analytical data (internal and external) with scientific rigor and appropriate documentation.
- Partner with Research, Process Development, Translational Sciences, and early CMC stakeholders to align analytical outputs with program needs.
- Contribute to analytical strategy and drive continuous improvement in assay robustness, experimental design, CRO engagement, and data quality.
Qualifications:
- PhD with 5+ years; or BS/MS with 8+ years (or equivalent).
- 4+ years analytical development experience in biotech/pharma research, ideally biologics and/or cell & gene therapy.
- Hands-on molecular/biochemical methods (e.g., ddPCR, MSD, ELISA, Flow, NGS).
- Experience designing/executing assay development, qualification, and validation.
- Experience working in a GCP-compliant environment.
- Experience managing outsourced analytical work at CROs.
- Strong understanding of assay fitness-for-purpose, data quality, and comparability.
- Ability to function as individual contributor and scientific leader; excellent communication.
Preferred:
- Regulatory BioA experience (GCP, GLP).
- Clinical development and site management experience.
- Experience with fast-paced/dynamic environments.
- Experience communicating, mentoring, and leading.