Senior Scientist, Lead Analytical Development Operations

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

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Senior Scientist, Lead Analytical Development Operations

AtOXB, our people are at the heart of everything we do.We’reon a mission to enable life-changing therapies to reach patients around the world—andwe’relooking for passionate individuals who embody our core values every day:Responsible, Responsive, Resilient, and Respectful.

We are currently recruiting for a Senior Scientist, Analytical Development Operations to join the Analytical Developmentteamin our Bedford, MA location. Reporting to the Vice President of Development Services , the purpose of the role is providing 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, playing a key part in advancing our mission and making a real difference.

Your responsibilities in this role would beto:

• 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.

We are looking for:

• 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.

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

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 manufacturingexpertisein lentivirus, adeno-associated virus (AAV),adenovirusand other viral vector types. OXB’s world-class capabilities range from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analyticalmethodsand depth of regulatoryexpertise.

OXB offers a vast number of technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (theTetraVecta™ system), a dual-plasmid system for AAV production, suspension and perfusion process using process enhancers and stable producer and packaging cell lines.

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

Why Join Us?

Wellbeing programsthat support your mental and physical health

Career development opportunitiesto 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

We want you to feel inspired every day. At OXB,we’refuture-focused and growing fast. We succeed together—through passion, commitment, and teamwork.