Lead Analytical Development Scientist – GMP Method Transfer

Oxford Biomedica; Bedford, Northern (MA, KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Wellbeing programs

Career development opportunities

State-of-the-art labs

Job summary

Oxford Biomedica in Bedford, MA is seeking a Senior Scientist, Analytical Development Operations to lead analytical development programs for viral vector processes. You will guide method development, transfers, and QC reporting while coordinating cross-functional teams with client-facing interactions.

The role requires a strong track record in analytical development within GMP environments, with focus on ddPCR/qPCR, ELISA, HPLC and related assays.

Qualifications

• 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.

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

Cross-functional leadership

Client-facing discussions

Analytical method development

GMP knowledge

Data trending & analysis

Education

Bachelor's degree in biology, chemistry or equivalent

Tools

ddPCR

qPCR

ELISA

HPLC

CE-SDS

LCMS

Flow cytometry

Job description

Oxford Biomedica in Bedford, MA is seeking a Senior Scientist, Analytical Development Operations to lead analytical development programs for viral vector processes. You will guide method development, transfers, and QC reporting while coordinating cross-functional teams with client-facing interactions.

The role requires a strong track record in analytical development within GMP environments, with focus on ddPCR/qPCR, ELISA, HPLC and related assays.