Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

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 FDB and help manufacture the next vaccine, cure, or gene 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.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

About the Role

The Quality Control (QC) Analytical Development (AD) Raw Materials (RM) Scientist II is responsible for coordinating the transfer of analytical methods for raw materials into the FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN) Quality Control Laboratory and external contract laboratory organizations (CLOs). This role liaises with customers, CLOs, QC testing teams, and QA groups to plan and track QC RM readiness for clinical and commercial manufacturing, which includes ensuring training needs, internal procedures, specifications, and protocols are met. The QC AD RM Scientist II serves as a subject matter expert (SME) in cross-functional teams to assess testing approaches, determine internal and external laboratory verification and validation needs, and provide technical support for troubleshooting new material testing investigations. This role performs change control assessment activities for tech transfers, including handling changes from customers on customer-owned materials, and onboarding new and generic raw materials, consumables, test laboratories, and specifications. The Scientist II authors, reviews, and approves protocols and reports, including specification justification reports (SJRs) and transfer summary reports, to support method tech transfer activities. This role also supports LIMS builds for new materials and ensures compliance with all GMP (Good Manufacturing Practices) regulatory guidelines.

What You'll Do

• Represents QC Analytical Development on internal and external tech transfer meetings related to the introduction of new materials for the manufacture of biological drug substances and drug products.
• Engages with customers about customer owned and Fujifilm Diosynth Biotechnologies owned materials.
• Creates overviews, tracks and manages activities for raw material implementation (test strategy, test site, method transfer plan), providing clear timelines and progress updates to stakeholders.
• Transfers analytical methods for testing and disposition of incoming raw materials and components according to specifications and procedures.
• Develops plans and monitors progress for incoming and ongoing change controls for program items and vendor change notifications.
• Authors/reviews/approves analytical method transfer plans, documents and reports (specification justification reports (SJRs) and technical summary reports (TSRs) for compendial and non-compendial methods, and change control assessments to support tech transfer activities.
• Provides RM testing compendial method oversight and ensure compliance with GMP guidelines, e.g. ICH, EMA, FDA, etc.
• Reviews new and updated specifications and request LIMS builds.
• Supports and participates in regulatory audits and client inspections.
• Lead cross-functional collaboration with QC Analytical Development, QC Program Management, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives.
• Provides technical expertise on investigations for Out of Specification (OOS) results.
• Provide support and guidance to internal QC stakeholders.
Perform other duties as assigned.

Minimum Requirements:

• B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 9+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO)

• Master’s degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 6+ years’ experience
• 4- 6 years relevant experience, experience in a GMP environment

Preferred Requirements:

• PhD. degree in Chemistry, Biochemistry, Biology, Microbiology, or other relevant scientific discipline with 3+ years’ experience
• 4-6 years of GMP/GxP with master’s degree OR
• 1-3 years of experience in a GMP/GxP with Ph.D. or a comparable federally regulated environment
• In-depth knowledge of Raw Material methodology as it pertains to cGMP.
• Experience in assay troubleshooting and problem solving

Physical and Work Environment Requirements:

Will work in environment which may necessitate respiratory protection

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Abiltiy to stand for prolonged periods of time up to 120 minutes

Abiltiy to sitfor prolonged periods of time up to 120 minutes

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Will work in warm/cold environments

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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.