Senior Scientist, Analytical Development

Overview

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Senior Scientist, Analytical Development will report directly to the Associate Director, Quality Control at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for developing, executing, and/or qualifying bioassays including but not limited to cell counting, T-cell activation, proliferation, or flow cytometry. They will author, review and approve analytical methods, laboratory procedures, method development reports, method qualification protocols/reports, risk assessments, and technical reports.

External US

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

The Senior Scientist, Analytical Development is an individual contributor responsible for analytical method development, characterization testing, data analysis and report for multiple cell types in support of cell therapy manufacturing processes.  The candidate will serve as subject matter expert for various analytical techniques.  The candidate must be able to quickly adapt and learn new techniques and methodologies as well as implement new processes and procedures in the laboratory.  The role requires strong technical expertise, communication, leadership, and project management skills.  The candidate must have strong laboratory skills, bioassay, cell biology and immunology experience.  Role requires a self-motivated, detailed oriented, flexible, and creative expert, able to prioritize, multi-task, and work in a fast-paced & demanding environment.

Reports to: Sr Manager Analytical Development

Location: Thousand Oaks, CA

Travel: Up to 10%

Primary Responsibilities:

• Develop, execute, and/or qualify bioassays including but not limited to cell counting, T-cell activation, proliferation, or flow cytometry
• Complete data analysis, review, report and communicate results
• Develop procedures for laboratory equipment use and maintenance
• Develop assay templates that can serve as platforms for multiple cell types or methods, as applicable
• Author, review, and approve laboratory procedures
• Support instrument qualifications and change control assessments
• Author, review and approve analytical methods, laboratory procedures, method development reports, method qualification protocols/reports, risk assessments, and technical reports
• Identify and qualify critical reagents required for analytical methods
• Train Analytical Development and/or Quality Control staff members in analytical methods, equipment operations, data analysis and reporting
• Assess analytical method performance
• Maintain current knowledge base of ICH Guidelines, regulations, and policies to ensure that the function remains in compliance with applicable company requirements and global regulations.
• Interface with other departments to ensure achievement of FDBCs objectives

Qualifications

• Senior Scientist: Bachelor of Science (B.Sc.) with 7 years of experience or an equivalent combination of education; or Master of Science (M.Sc.) with 5 years of experience; or PhD in Science with 3 years of experience

• Advanced knowledge in analytical methods and respective instrumentation
• Advanced knowledge of product testing and laboratory skills
• Advanced knowledge of computer and laboratory systems
• Excellent technical writing, communication skills, project management skills and proved experience leading projects and achieving results with outstanding outcomes
• Strong experience in cell culture, analytical method development and qualification (bioassays, flow cytometry and other techniques performed for cell therapy)
• Experience in statistical analysis
• Independent decision-making capability and ability to think conceptually and understand impact of decisions critical
• Ability to work independently, able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary
• Organizational skills and ability to manage multiple projects at the same time
• Team player and good interpersonal skills
• Knowledge of relevant regulations and regulatory guidance
• Experience in GMP and method validation preferred
• Experience working in a contract manufacturing or testing organization is preferred
• Flexibility to travel as required to accommodate the business needs
• Role model for FDBC values (Trust, Delighting our Customers, Gemba, Genki).

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.