Senior Scientist, Lead Analytical Development Operations
About The Position
OXB is recruiting a Senior Scientist to join its Analytical Development team in Bedford, Massachusetts. Reporting to the Vice President of Development Services, this role provides 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. The position leads analytical development operations, including client-work status, FTE, cost models, and material inventory. It supports qualification, transfer, validation, and verification of GMP analytical methods and serves as a technical subject matter expert in client and project discussions. The role also supports ongoing method-performance monitoring, troubleshooting, cross-functional analytical services, and the development of associates and scientists. This role does not offer work-authorization sponsorship. External applicants must be eligible to work in the United States.
Requirements
- Bachelor’s degree in biology, chemistry, or equivalent.
- 10+ years of related post-degree experience.
- Proven ability to lead cross-functional teams and client-facing technical discussions.
- Extensive experience in analytical method development, qualification, and technology 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, or reviewing operational SOPs, technical documents, protocols, and reports.
- Eligible to work in the United States; the role does not offer sponsorship for work authorization.
Nice To Haves
- Advanced degree preferred.
Responsibilities
- Lead analytical development operations, including tracking client work, FTE, cost models, and material inventory.
- Ensure Analytical team members write protocols and generate reports for QC method transfer, validation, and verification activities.
- Support qualification, transfer, validation, and verification of GMP analytical methods, including ddPCR, qPCR, ELISA, HPLC, capillary electrophoresis (CE-SDS), LCMS, and cell-based assays such as TCID50, gene expression, flow cytometry, and potency assays.
- Serve as a subject matter expert during client meetings, project reviews, and technology-transfer discussions; build client relationships and support business-development opportunities as needed.
- Support monitoring of ongoing analytical method performance, such as system-suitability trending, to drive continued improvement and optimization of OXB’s analytical methods.
- Assist with trending assay controls and reference standards as needed.
- Lead and support analytical troubleshooting as needed.
- Partner with internal and cross-functional departments, including QC, Internal QA, and External QA, to ensure the success of the analytical services program.
- Present to cross-functional teams and communicate critical analytical issues and solutions effectively.
- Mentor and develop associates and scientists in Analytical Development.
Benefits
- Competitive total reward packages.
- Wellbeing programs supporting mental and physical health.
- Career development opportunities.
- Supportive, inclusive, and collaborative culture.
- State-of-the-art laboratories and manufacturing facilities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
