Senior Process Scientist/Engineer (Upstream)

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Location :
Morrisville, North Carolina

Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT

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Senior Process Scientist/Engineer (Upstream) Join our team of passionate and scientists as we drive cutting-edge biopharmaceuticals from R & D lab to commercialization. Our Senior Process Scientist/Engineers are responsible for many aspects of technical transfer of a wide variety client projects into our manufacturing facilities. From first clinical batch, to PPQ, to Pre-Approval Inspection – you will be there. No two days are alike. Our Senior Engineers troubleshoot complex technical issues to support project success. Senior Engineers provide comprehensive technical solutions throughout the organization. If you are ready to grow your career, work hard, and make a substantial impact in patients’ lives consider joining our team.The successful candidate has relevant experience as it relates to the upstream process(Cell Culture, Fermentation, Aseptic technique, Recovery) tech transfer (scale up support, authoring or experience with technical documents, protocols, summary reports, creating BOM, process risk assessment, writing detailed process description),new product introduction through PPQ, process troubleshooting, Change control, deviation support, data analysis, lean six sigma experience, process risk assessment, formulation record, batch record, PPQ document support, inspection support. Technical writing experience, internal cross functionalteam interaction and client interaction support.The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We’re 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 create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drivewhat FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.MAJOR ACTIVITIES AND RESPONSIBILITIES:ResponsibilitiesResponsible for aspects of technical transfer or process validation of client projects in and to manufacturing as applicableLatitude for independent judgmentSupport capital projects by providing technical expertiseSolve complex engineering projectsMay be responsible for new project site-fit assessments as neededApply engineering design principlesDemonstrate production troubleshooting knowledgeIdentify process improvements and implementProficienciesUnderstanding and command of aspects of biotechnology, bio-production and associated technologies including fermentation, cell culture, and purification of regulated biopharmaceuticalsExperience in Tech Transfer or Process Validation of biopharmaceutical processesAble to apply advanced computer systems, and relevant instrumentation and data analysis knowledge to complex and unusual situationsApplies advanced scientific and engineering knowledge associated with larger and more complex projects.Defines and implements strategies, initiatives, and actions to improve processes and procedures to ensure compliance with internal and regulatory standards.Partners across company functions and collaborates effectively with respect to identifying and addressing problems and opportunities that affect or require input from multiple units within the company. Capable of developing a facility fit strategy for programs based on limited client dataSupervisionWork under minimal supervision on complex projects and may assist less experience peersA resource to colleagues within the function. Presents his or her own original ideas and research findings.Works with cross-functional teams to solve problems or to develop products. Problem SolvingDevelops technical and/or system solutions. Effectively benchmarks available technologies relative to other companies or industries. Implementation of new technologies within area.Contributes strong technical advice to team problem solving.Contributes to decisions on technical information generated.Possesses a solid understanding of the research literature associated with own scientific discipline; stays informed of current trends via journals, patents and personal networks of internal and external experts.Oral & Written CommunicationWrite, edit and review of SOPs/proceduresAuthoring and review of qualification/validation/tech transfer protocols or reportsWrites and reviews departmental and inter-departmental reports for internal and external distribution.Contributes to cross-functional communication across FFDB.Direct communication with clients to communicate technical items and to resolve issues.Direct communication with regulatory agencies, industry experts and consultants.Significant impact on department performance; drives department results; impact is achieved primarily by personal efforts or leading others.BACKGROUND REQUIREMENTS:BS (preferably Chemical Engineer, BioEngineering, or Basic Science only with directly relevant experience) and 7+ years or equivalentMS and 5+ years or equivalentPhD and < 4 years or equivalent2+ years of biotech industry experienceBiologics Experience requiredGMP Experience:Senior Process Engineer is a mid-level position in the Process Sciences/Technical Operations department of FDBU, a minimum of five years of GMP experience is required.FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.FDBU 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.