Scientist 1, Global QC Analytical Development Raw Materials Position Available In Wake, North Carolina

Job Description:

FUJIFILM

Diosynth Biotechnologies is building the future ofbioproduction in Holly Springs, North Carolina. By end of 2025,we’ll open North America’s largest end-to-end CDMObiopharmaceutical manufacturing facility, offering drug substanceproduction, fill-finish, and packaging under one roof. We’relooking for passionate, mission-driven people to help us realizethis exciting vision and deliver the next vaccine, cure, ortherapy. We offer a dynamic work environment and we’re proud tocultivate a culture that will fuel your purpose, energy, anddrive—what we call Genki. Ready to shape the future of medicine?

Let’s transform healthcare together! Holly Springs, North Carolina,combines small-town warmth with proximity to Raleigh’s thrivingtech scene, making it the perfect blend of community andopportunity. What Youll Do

• Serves as a subject matter expert(SME) in cross-functional teams to assess testing approaches,determine internal and external laboratory verification andvalidation needs, and provide technical support for troubleshootingnew material testing investigations
• Represents Global QCAnalytical Development on internal and external tech transfermeetings related to the introduction of new materials for themanufacture of biological drug substances and drug products
• Engages with customers about customer controlled and FujifilmDiosynth Biotechnologies controlled materials
• Creates overviews,tracks and manages activities for raw material implementation (teststrategy, test site, method transfer plan), providing cleartimelines and progress updates to stakeholders
• Performs changecontrol assessment activities for tech transfers, includinghandling changes from customers on customer-controlled materials,and onboarding new and generic raw materials, consumables, testlaboratories, and specifications
• Transfers analytical methods fortesting and disposition of incoming raw materials and componentsaccording to specifications and procedures
• Develops plans andmonitors progress for incoming and ongoing change controls forprogram items and vendor change notifications
• Authors, reviews,and approves analytical method transfer plans, documents andreports (specification justification reports (SJRs) and transfersummary reports (TSRs) for compendial and non-compendial methods,and change control assessments to support tech transfer activities
• Provides RM testing compendial method oversight and ensurecompliance with GMP guidelines, e.g. ICH, EMA, FDA, etc.
• Supportsand participates in regulatory audits and client inspections
• Leads cross-functional collaboration with QC AnalyticalDevelopment, QC Program Management, Manufacturing, Process Science,and Quality Assurance stakeholders to achieve customer and FUJIFILMDiosynth Biotechnologies objectives
• Provides technical expertiseon investigations for Out of Specification (OOS) results
• Providessupport and guidance to internal QC stakeholders
• Performs otherduties as assigned

Minimum Requirements:

• Bachelor’s Master’s inchemistry, Biochemistry, Microbiology or other relevant scientificdiscipline with 5 years’ experience OR
• Master’s in chemistry,Biochemistry, Microbiology or other relevant scientific disciplinewith 3 years’ experience OR
• PhD with 1 years of applicableindustry experience
• 4-6 years of experience in a federallyregulated GMP environment
• 4 years’ experience in a GMPenvironment
• Experience with method transfers

PreferredRequirements:

• In-depth knowledge of Raw Material methodology asit pertains to cGMP
• Experience in assay troubleshooting andproblem solving

Physical and Work Environment Requirements:

• Ability to discern audible cues.
• Ability to inspect or perform atask with 20/20 corrected vision, visual acuity, includingdistinguishing color.
• Ability to stand for prolonged periods oftime up to 240 minutes.
• Ability to sit for prolonged periods oftime up to 240 minutes.
• Ability to conduct activities usingrepetitive motions that include wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10pounds.
• Ability to bend, push or pull, reach to retrievematerials from 18″ to 60″ in height, and use twisting motions.
• Will work in warm/cold environments (5 C)
• Will work in smalland/or enclosed spaces.