Senior Scientist II (Analytical Development)

Location: Bedford, MA, US

About Us

OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, OXB has 30 years of experience in viral vectors; the driving force behind the majority of cell and gene therapies. OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV), adenovirus, and other viral vector types.

OXB’s world-class capabilities range from early-stage development to commercialisation, supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise. OXB offers a vast number of technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (the TetraVecta™ system), a dual-plasmid system for AAV production, suspension and perfusion processes using process enhancers, and stable producer and packaging cell lines.

OXB, a FTSE250 and FTSE4Good constituent, is headquartered in Oxford, UK, with development and manufacturing facilities across Oxfordshire (UK), Lyon and Strasbourg (France), Bedford (MA), and Durham (NC, US).

About the Role

We’re looking for 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.

Responsibilities

• Lead analytical development operations, including status of client work, FTE, cost model, and material inventory.
• 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, and cell-based assays (e.g., TCID50, gene expression, flow cytometry, and potency).
• Serve as a subject matter expert during client meetings, project reviews, tech transfer discussions, and build client relationships to support business development opportunities as needed.
• Support monitoring of ongoing 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.
• Partner with internal and cross-functional departments (e.g., QC, Internal QA, External QA) to ensure the 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.
• QC experience is a plus.
• 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.
• Experience with a CDMO environment is highly desirable.

Pay

The salary range for this position is $145,000 - $170,000 per year. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. This position may be eligible for performance-based bonuses.

Benefits

• Health insurance
• 401k contributions
• Paid time off (PTO)
• Tuition reimbursement

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

Why Join Us?

• Competitive total reward packages
• Wellbeing programs that support your mental and physical health
• Career development opportunities to help you grow and thrive
• Supportive, inclusive, and collaborative culture
• State-of-the-art labs and manufacturing facilities
• A company that lives its values: Responsible, Responsive, Resilient, Respect