Senior Scientist II

oxfordbiom•New Bedford, MA

1d•$145,000 - $170,000•Onsite

About The Position

OXB is seeking a Senior Scientist, Analytical Development, to provide scientific and operational leadership for analytical method development, qualification, transfer, and lifecycle management supporting viral vector process development and GMP manufacturing programs. This role will oversee analytical development activities for AAV and other viral vector platforms, ensuring robust characterization strategies, successful technology transfers, regulatory compliance, and delivery of high-quality analytical data to support client programs. The individual will serve as a key technical and client-facing representative, partnering closely with Process Development, Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, and external clients to ensure successful execution of development and manufacturing projects. This is an onsite role based in Bedford, MA.

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/reviewing operational SOPs, technical documents, protocols, and reports.
Strong written and verbal communication skills

Nice To Haves

QC experience is a plus
Experience with CDMO environment is highly desirable

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
Lead and support method development, 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.