Sr. Advisor - Analytical Development

Responsibilities

• Analytical Strategy & LVV Bioassay/Potency Leadership
• Define and execute analytical development and control strategies across the product lifecycle.
• Lead end-to-end development, optimization, qualification, and validation of LVV bioassays and potency assays.
• Drive potency assay comparability and bridging across process changes, manufacturing site transfers, and reference standard updates.
• Provide scientific guidance on product characterization, comparability, and control strategy.
• Partner with Regulatory and Quality to align potency strategy with evolving FDA/EMA expectations for advanced therapies.

Method Lifecycle, Characterization & Technology

• Development, optimization, and troubleshooting of methods across the broader LVV/gene therapy analytical panel.
• Define qualification, validation, and lifecycle strategies with emphasis on bioassay/potency methods.
• Partner with Operations and Quality on successful method transfer, including complex cell-based bioassays.
• Drive implementation of novel analytical technologies, including next-generation potency and bioassay platforms.

Led Leadership, Mentorship & Regulatory Engagement

• Mentor and develop scientists across the analytical organization.
• Build bench strength in bioassay and potency assay science.
• Serve as the primary analytical SME in cross-functional and technical review settings.
• Author and review analytical/potency sections of regulatory submissions and technical reports.
• Support health authority interactions and inspections as an analytical SME.
• Provide scientific oversight of external analytical development activities and technology transfers.
• Maintain awareness of emerging technologies and regulatory expectations.

Basic Requirements

• PhD in analytical chemistry, biochemistry, molecular biology, pharmaceutical sciences, or a related discipline with 5+ years of industry experience; or MS with 12+ years of industry experience.
• Extensive, hands-on experience developing, optimizing, qualifying, and validating late-stage lentiviral vector bioassays and cell-based potency assays.
• Demonstrated expertise in analytical development within cell and gene therapy, biologics, viral vectors, or related advanced modalities, including method transfer to internal/external labs and CMC support from early through late-stage development.

Additional Preferences

• Recognized expertise in LVV bioassay/potency science (surrogate potency, matrix approaches, multi-attribute methods).
• Demonstrated success leading complex technical programs.
• Experience supporting regulatory filings and health authority interactions, including potency-related BLA/MAA sections and inspection readiness.
• Strong leadership, mentoring, and communication skills, with the ability to influence scientific direction across stakeholders and a commitment to scientific excellence and talent development.