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Material Scientist

Employer
FUJIFILM Diosynth Biotechnologies
Location
Thousand Oaks, CA
Start date
Sep 14, 2022
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Job Details

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Material Scientist will report directly to the Director, Manufacturing Science and Technology at the FUJIFILM Diosynth Biotechnologies. The job holder will be responsible for carrying out activities in support of the manufacturing of cell therapy products, including sample analysis, report generation, and laboratory investigations. They will provide input on suitability of materials and single use components in the manufacturability assessment for Process Sciences.

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 Material Scientist is a critical leadership position, serving as a subject matter expert (SME) responsible for the successful evaluation, recommendation, and onboarding of new raw materials and single use components that will be used for production of external partner products and processes from project scoping activities through execution of GMP production.

Reports to                Director, Manufacturing Science and Technology

Work Location         Thousand Oaks, CA 

Travel                         Travel required (Up to 25%)

Primary Responsibilities:

  • Work with Manufacturing, Quality, and Supply Chain to develop a materials business process and generate associated supporting documentation.
  • Support evaluation of materials from development to commercial release and GMP production.
  • Assess material testing appropriateness to meet compendial or in-house testing and material specifications.
  • Carry out activities in support of the manufacturing of cell therapy products, including raw material sample analysis, report generation, laboratory investigations, and physical evaluation of potential impact to products.
  • Partner with Manufacturing, Supply Chain, and Quality teams to identify and drive optimization initiatives and address opportunities for material improvements and alternate sourcing.
  • Provide input on suitability of materials and single use components in the manufacturability assessment for Process Sciences during process development activities and for external clients during project scoping of early development products.
  • Lead new material introduction changes and projects.
  • Write component and system qualification plan and reports.
  • Develop, own, and maintain raw material specifications and control strategies.
  • Responsible for design of experiments and interpretation of the data.
  • Perform process capability assessments and root cause analysis.
  • Bring technical expertise and oversight by supporting supplier audits.
  • Provide significant raw material and single use component technical depth to support troubleshooting and investigational efforts.
  • Identify and develop new technologies applicable to materials to be used in manufacturing processes.
  • Establish communication pathways to ensure information 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.
  • Identify and mitigate material risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
  • Ensure effective risk management processes are implemented to prevent unanticipated material failure modes, negatively impact production operations and planning.
  • Work cooperatively with site leaders to implement programs to improve overall quality, improve operational efficiency, enhance organizational capability, and assure regulatory compliance.

Physical Demand:

  • 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.

Qualifications:

  • Bachelor's degree in Analytical Chemistry, Pharmaceutics, or related scientific field (advanced degree preferred).
  • 5+ years of experience within Technical Operations functions (e.g., Supply Chain, Manufacturing, Quality) working for a pharmaceutical, biotechnology, biologics company, or related industry.
  • Strong communication skills (e.g., clear, and concise), team player, and proven negotiation skills.
  • Good decision making.
  • Strong understanding of pharmaceutical supply chain for cell therapy manufactured materials, components, and products.
  • Demonstrates strong client service skills, teamwork, and collaboration.
  • Self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.
  • Deep knowledgeable of CFRs and GMPs; specifically, those related to raw materials and single use components.
  • Experienced at material and component, system, and equipment troubleshooting.
  • Skilled and knowledgeable in material investigations including particulate matter and material/component failure.
  • Successfully worked in an environment with high quantitative performance measurements.
  • Mindset for continuous improvement, innovation, and problem solving in an evolving environment.
  • Must have a strong sense of ownership and a commitment to deliver quality in all aspects of the role.
  • Role model for company core values of trust, delighting our customers, Gemba, and 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.

Company

FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.

With over 30 years of experience in process development and cGMP manufacturing, a dedicated staff of over 2,000 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.

Our Process Development experience includes the development of processes for molecules expressed via fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.

Our network expands within five development and manufacturing facilities located in Teesside, United Kingdom; Research Triangle Park, North Carolina, USA; College Station, Texas, Thousand Oaks CA USA and Hillerød, Denmark.

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Find Us
Website
Phone
919-337-4400
Location
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Watertown, MA
United States
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