Sr. Director Analytical Sciences

SUMMARY

The Senior Director, Analytical Sciences will provide strategic technical and operational leadership for the internal and external analytical development/GMP testing functions supporting our company’s gene therapy product portfolio. This role will oversee the design and execution of internal analytical testing for process development, drive the innovation of new analytical assays, and technically drive the end-to-end transfer and validation of these assays to external QC laboratories including technical investigations supporting GMP release.  The role must partner successfully cross-functionally within Technical Development and across Technical Operations.  This is a full-time hybrid position (3 days a week) in our Somerville, Massachusetts office.

The ideal candidate will bring deep expertise in cell and gene therapy (CGT) analytical development, a track record of successful assay development and tech transfers, and the leadership acumen to bridge the gap between early scientific assay development and commercial QC operations.

RESPONSIBILITIES

Analytical Strategy

• Provide strategic oversight and day-to-day management of analytical workflows internally and externally
• Define the analytical strategy for ensuring alignment with process development milestones and regulatory requirements
• Partner closely with Process Development to provide rapid analytical testing for process optimization and comparability studies.
• Propose and drive the development of life cycle management of analytical control strategies, including assay updates and assay replacements
• Actively participate in establishing the appropriate technical rigor and additional characterization assays needed to support strategic decisions for analytical comparability

New Assay Development & Innovation

• Lead a high-performing team of scientists in the design, development, qualification, and routine testing of novel assays
• Drive innovation in analytical platforms to improve assay sensitivity, throughput, and robustness, specifically tailored for complex cell therapies and considering the appropriate level of automation
• Ensure all new methods are developed with a "right first time" approach to facilitate seamless transition to a GMP environment

External (from Tech Transfer to Investigations)

• Acts as the ultimate technical authority for Analytical Sciences for the technical transfer of analytical methods from internal to external quality control laboratories
• Oversee the design and execution of method validation at external sites, ensuring successful implementation and compliance with regulatory standards.
• Manage troubleshooting, OOS/OOT investigations, and method lifecycle management with a focus on removing barriers to ensure the path to curative treatments remains clear.

Cross-Functional Leadership & Compliance

• Collaborate across CMC to support regulatory submissions and inquiries.
• Author and review high-quality technical reports, SOPs, and CMC sections of regulatory filings.
• Build and mentor a world-class analytical sciences team, fostering individual team member career development while in parallel maintaining a culture of scientific rigor and operational excellence.
• Manage resource allocation and timelines to ensure program delivery.

 Qualifications

• Education: Ph.D. in Biochemistry, Molecular Biology, Analytical Chemistry, or a related scientific discipline.
• Experience: 10+ years of progressive experience in the biopharmaceutical industry, with at least 5 years in a people management role specifically within Analytical Development for Cell and Gene Therapies, with title commensurate with experience.
• Technical Expertise: Deep hands-on and strategic knowledge of cell therapy analytical techniques (Multicolor Flow Cytometry, ddPCR, Cell-based Potency, ELISA, CFU, etc.). Ideal candidate will have prior CD34+ and/or viral vector experience.
• Track Record: Proven success in transferring and validating assays at external CDMOs/CROs and supporting successful regulatory filings (IND/BLA/MAA) including resolving root cause investigations.
• Communication: Exceptional verbal and written communication skills, with the ability to translate complex analytical data into strategic insights for senior leadership.