Senior Scientist, Lead Analytical Development Operations, US

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

Select how often (in days) to receive an alert:

Senior Scientist, Lead Analytical Development Operations, US

Location: Bedford, MA, US

Company: oxfordbiom

We use science to save lives, and so can you .

We are looking to recruit a Senior Scientist, Analytical Development, that will provide 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. This role will oversee routine 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 within the analytical development group.

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 onsite Bedford, MA based role is an exciting opportunity to join an experienced organization whose mission is to enable our clients to deliver life-changing therapies to patients.

Your responsibilities in the role will be:

• 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
• 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
• 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.
• Able to work effectively in a collaborative team environment
• Strong written and verbal communication skills
• Experience with CDMO environment is highly desirable

About Us:

OXB is a quality and innovation-led viral vector CDMO (Contract Development and Manufacturing Organization) 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, we have more than 25 years of experience in viral vectors; the driving force behind the majority of 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, and adenoviral vectors. Oxford Biomedica’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise

What’s in it for you:

• Competitive reward packages
• Welcoming, friendly, supportive colleagues
• A diverse and inclusive working environment
• State of the art laboratory and manufacturing facilities

We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment, and teamwork, and so can you.

At OXB (US) LLC we are committed to providing equal opportunity to all employees and applicants. Our policy is to recruit, hire, train, and reward employees for their individual abilities, achievements, and experience without regard to race, colour, religion, sexual orientation, age, national origin, disability, marital or military status.

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