Senior Scientist, Lead Analytical Development Operations

OXB is recruiting for a Senior Scientist, Analytical Development Operations to join the Analytical Development team in Bedford, MA. Reporting to the Vice President of Development Services, the purpose of the role is providing scientific and operational leadership for analytical method development operations and systems, qualification, transfer, and lifecycle management supporting viral vector process development and GMP manufacturing programs.

Responsibilities

• Lead analytical development operations including status of client work, FTE, cost model, and material inventory, and ensure Analytical team members write protocols and generate reports related to QC method transfer, validation, and verification activities.
• Support qualification, transfer, validation, and verification of GMP analytical methods including but not limited to ddPCR, qPCR, ELISA, HPLC, capillary electrophoresis (CE-SDS), LCMS, and cell-based assays (e.g. TCID50, gene expression, flow cytometry, and potency).
• Serve as subject matter expert during client meetings, project reviews, and tech transfer discussions, as well as build client relationships and support business development opportunities as needed.
• Support monitoring of on-going analytical method performance (e.g. system suitability trending) to drive continued improvement and optimization of OXB's analytical methods.
• Assist with data trending of assay controls and reference standards, as needed.
• Lead and support analytical troubleshooting, as needed.
• Partner with internal and cross-functional departments (e.g. QC, Internal QA, External QA) to ensure success of the analytical services program.
• Present to cross-functional teams and effectively communicate critical analytical issues and solutions.
• Mentor and develop associates and scientists in analytical development.

Requirements

• Bachelor's degree in biology, chemistry, or equivalent; advanced degree preferred.
• 10+ years of related experience post-degree.
• Proven ability to lead cross-functional teams and client-facing technical discussions.
• Extensive experience in analytical method development, qualification, and tech transfers.
• Demonstrated expertise in analytical method development supporting viral vectors for gene therapy.
• Knowledge of quality principles and GMP, ICH, and GLP regulations.
• Familiarity with HPLC, AUC, CE-SDS, ELISA, ddPCR, qPCR, and cell-based assays.
• Experience creating, revising, and reviewing operational SOPs, technical documents, protocols, and reports.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.