Lead Analytical Development Scientist - Viral Vector Ops

Oxford Biomedica; Bedford (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

OXB in Bedford, MA is seeking a Senior Scientist, Analytical Development Operations to lead analytical development activities and oversee method transfer, qualification, and lifecycle management for viral vector programs. The role focuses on developing and validating analytical methods (ddPCR, qPCR, ELISA, HPLC, CE-SDS, LCMS) and ensuring regulatory compliance.

The candidate will partner with Process Development, Manufacturing, Quality Control, Regulatory Affairs, and external clients to drive

Qualifications

• Bachelor's degree in biology, Chemistry or equivalent; advanced degree preferred.
• 10+ years of related experience post-degree.
• Independently motivated, detail oriented and strong problem-solving ability.
• Proven ability to lead cross-functional teams and client-facing technical discussions.
• Extensive experience in analytical method development, qualification and tech transfers.

Responsibilities

• Lead analytical development operations including status of client work, FTE, Cost model, 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, Cell-based Assays (e.g. TCID50, Gene expression, flow cytometry, and Potency).
• Serve as subject matter expert during client meetings, project reviews, 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.
• Partners with internal and cross-functional departments (e.g. QC, Internal QA, External QA) to ensure success of analytical services program.
• Presentation to cross-functional teams and effectively communicate critical analytical issues and solutions.
• Mentor and develop associates and scientists in analytical development.

Skills

Analytical Dev

Tech Transfer

Client-facing

GMP/ICH

HPLC

qPCR/ddPCR

Cell-based Assays

Education

Bachelor's degree

Advanced degree preferred

Tools

HPLC

CE-SDS

LC-MS

qPCR

ddPCR

Flow Cytometry

Job description

OXB in Bedford, MA is seeking a Senior Scientist, Analytical Development Operations to lead analytical development activities and oversee method transfer, qualification, and lifecycle management for viral vector programs. The role focuses on developing and validating analytical methods (ddPCR, qPCR, ELISA, HPLC, CE-SDS, LCMS) and ensuring regulatory compliance.

The candidate will partner with Process Development, Manufacturing, Quality Control, Regulatory Affairs, and external clients to drive