Senior Associate, Material Sciences

Overview

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 Associate, Material Sciences is a critical position, serving as a subject matter expert (SME) responsible for the successful support to evaluate, recommend, and onboarding of new raw materials and single use components as well as second sourcing and updates to existing materials, that are and will be used for production of external partner products and processes from project scoping activities through execution of GMP production.

 

External US

Material Sciences; Senior Associate

Department: Manufacturing Sciences & Technology (MSAT)

 

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.

 

Position Summary

The Senior Associate, Material Sciences is a critical position, serving as a subject matter expert (SME) responsible for the successful support to evaluate, recommend, and onboarding of new raw materials and single use components as well as second sourcing and updates to existing materials, that are and will be used for production of external partner products and processes from project scoping activities through execution of GMP production.

 

Reports to: Senior Scientist/Principal Scientist Material Sciences, Manufacturing Science and Technology (MSAT)

 

Location: FujiFilm Diosynth Biotechnologies, Thousand Oaks, CA (FDBC)

 

Primary Responsibilities

• Work with MSAT, Manufacturing, Quality, and Supply Chain to support and advance the evaluation of materials from development to commercial release and GMP production
• Support evaluation of materials from development to commercial release and GMP production
• Support assessments of material testing appropriateness to meet compendial or in-house testing and material specifications
• Support suppliers and materials change notifications
• Support alternative sourcing of suppliers and materials
• Partner with Manufacturing, Supply Chain, and Quality teams to implement optimization initiatives and opportunities for material improvements and alternate sourcing
• Support evaluation of materials suitability and single use components in assessment from Process Development
• Support new material introduction changes and projects
• Support supplier audits
• Support raw materials troubleshooting and investigational efforts
• Ensure robust communication so that information is shared appropriately at all levels including escalation pathways to leadership
• Contribute to a culture that embraces the safety of the work environment and the safety of patients by complying with company procedures and policies and cGMP cell culture manufacturing requirements
• Support mitigations to material risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients
• Support material risk management processes and evaluations
• Work cooperatively with MSAT team and functional area leaders to support programs to improve overall quality, improve operational efficiency, enhance organizational capability, and assure regulatory compliance
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Travel: Travel required (up to 25%)

 

Physical Demands:

Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, manufacturing plant, or clinical environment.  Car and airplane (see above) travel is an essential part of the job.

 

Position Requirements: