Director of Analytical Development

About the Role

This leadership role sits within Quality Control and takes ownership of the analytical backbone of QC operations — from method performance and transfer through specifications, reference standards, and supplier oversight. The person in this role builds strong working relationships across CMC and with outside partners, driving the operational strategy that keeps analytical work compliant, current, and ready for scrutiny at any stage.

A hybrid role based in the greater Boston area, with regular in-person collaboration expected several days each week.

Core Responsibilities

Leadership & Strategy

• Set direction for the QC Analytical function and the external partners supporting it
• Partner with Analytical Development and Process Development to keep CMC and QC strategy in sync
• Build and coach a team, with a real focus on professional growth

Technical Ownership

• Manage the full lifecycle of QC-owned methods — transfer, validation, monitoring, and refinement
• Direct reference standard strategy for late-phase programs through ongoing upkeep
• Own specifications as products move through their lifecycle
• Investigate and resolve OOS/OOT events and keep quality records in order

External & Regulatory

• Hold contract manufacturers and testing labs accountable to quality and regulatory standards
• Contribute to regulatory filings through CMC authorship and review
• Get QC teams inspection-ready, support audits, and represent QC analytical expertise when inspectors are on-site
• Translate data into clear updates for stakeholders on both sides of the table

Background We're Looking For

• Advanced degree (BS/MS/PhD) in a life science field, with 12+ years in the industry
• A strong analytical chemistry foundation, comfortable with compendial and non-compendial methods alike
• History of leading QC teams and managing outside labs/CMOs
• Fluency in cGMP, ICH, and FDA/EU regulatory expectations
• Hands-on background across techniques like size-exclusion and capillary electrophoresis methods, isoelectric focusing, peptide mapping, potency assays, and device functional testing
• A track record of developing people, not just managing them
• Ease with ambiguity and shifting priorities in a smaller, leaner organization
• High integrity and sound judgment
• Comfortable with standard Microsoft tools
• Open to light travel (~5%)
• Compensation based on experience