Scientist 1 Global QC Analytical Development Raw Materials

The Scientist 1 Global QC Analytical Development Raw Materials is responsible for coordinating the transfer of analytical methods for raw materials into the FUJIFILM Biotechnologies Diosynth 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 raw materials readiness for clinical and commercial manufacturing which includes ensuring
training needs internal procedures specifications and protocols are met. This role ensures compliance with all GMP (Good Manufacturing Practices)
regulatory guidelines.

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FUJIFILM Diosynth Biotechnologies 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 newlargescale 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 endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll Do

Serves as a subject matter expert (SME) in crossfunctional teams to assess testing approaches determine internal and external laboratory verification and validation needs and provide technical support for troubleshooting new material testing investigations
Represents Global 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 controlled and Fujifilm Diosynth Biotechnologies controlled 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
Performs change control assessment activities for tech transfers including handling changes from customers on customercontrolled materials and onboarding new and generic raw materials consumables test laboratories and specifications
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 and approves analytical method transfer plans documents and reports (specification justification reports (SJRs) and transfer summary reports (TSRs) for compendial and noncompendial 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.
Supports and participates in regulatory audits and client inspections
Leads crossfunctional 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
Provides support and guidance to internal QC stakeholders
Performs other duties as assigned

Minimum Requirements:

Bachelors Masters in chemistry Biochemistry Microbiology or other relevant scientific discipline with 5 years experience OR
Masters in chemistry Biochemistry Microbiology or other relevant scientific discipline with 3 years experience OR

PhD with 1 years of applicable industry experience
46 years of experience in a federally regulated GMP environment
4 years experience in a GMP environment
Experience with method transfers

Preferred Requirements:

Indepth knowledge of Raw Material methodology as it pertains to cGMP
Experience in assay troubleshooting and problem solving

Physical and Work Environment Requirements:

Ability to discern audible cues.

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

Ability to stand for prolonged periods of time up to 240 minutes.

Ability to sit for prolonged periods of time up to 240 minutes.

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

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

Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions.

Will work in warm/cold environments 5 C)

Will work in small and/or enclosed spaces.

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 viaemail 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.

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .