Sr. Analyst 1, QC Bioassay at Fujifilm

Position OverviewFUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: OverviewFUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof. Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together! Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: DescriptionAbout the RoleThe QC Bioassay Sr. Analyst 1 works with limited direction to execute QC cell- and plate-based analytical methods including protein binding assays cell-based potency assays cell culture routine maintenance and residual testing for DNA Host Cell Protein (HCP) Protein A/G. The QC Bioassay Sr. Analyst 1 adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identify laboratory exceptions invalid assays deviations change controls and corrective and preventative actions (CAPAs). The QC Bioassay Sr. Analyst 1 is primarily responsible for executing routine analytical methods in support of manufacturing supporting laboratory execution of analytical method transfers and validations and training other QC Bioassay laboratory associates. The ability to effectively communicate and function in a fast-paced highly technical environment is essential to success.What Youll Do Executes cell- and plate-based analytical methods including protein binding assays (e.g. ELISA Dot Blot etc.) cell-based potency assays cell culture maintenance and residual testing for DNA Host Cell Protein (HCP) Protein A/G Ensures analytical testing of in process drug substance (DS) drug product (DP) and stability samples are performed according to appropriate GMP regulations Ensures analytical testing data is captured in LIMS software and data integrity is maintained Reports assay performance and assists with implementing improvements that ensure quality and efficiency within QC Bioassay Identifies and follows-up on excursions and deviations and initiate corrective and preventative actions (CAPAs) Coordinates and supports QC Bioassay lab activities as needed Provides training for QC Bioassay lab associates Supports laboratory execution of analytical method transfers and validations Assists with authoring and reviewing SOPs and technical reports Works cross functionally with other QC departments Manufacturing Process Science and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives Performs other duties as assignedMinimum Requirements: B.S. in Microbiology Virology Biology Chemistry Biochemistry Biological Sciences or related science field with 3 years of experience 3 years laboratory experience 1-3 years GMP laboratory experiencePreferred Requirements: M.S. in Virology Microbiology Biology Chemistry Biochemistry Biological Sciences or related science field with 0 years of experience Experience with LIMS softwarePhysical and Work Environment Requirements:Ability to sit for prolonged periods of time up to 240 minutes.Ability to stand for prolonged periods of time up to 240 minutes.Ability to conduct work that includes moving objects up to 10 pounds.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.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 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.EEO InformationFujifilm 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.ADA InformationIf you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().Required Experience:Senior IC Key Skills Computer,IT Audit,CAD CAM,ABAP,Exterior Designing,HR Operations Employment Type : Unclear Department / Functional Area: Quality Control Experience: years Vacancy: 1