The Upstream Engineer/Scientist 3 will provide tech transfer support and technical oversight for a large-scale cell culture in monoclonal antibody manufacturing.
Company OverviewFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies 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 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 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.
Job Description
What You’ll Do
Conducts lab and pilot plant experimentsGenerates and coordinates execution sampling protocolsServes as subject matter expert (SME) to lead and conduct troubleshooting, process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviationsExecutes and analyzes lab and pilot plant work aimed at solving complex manufacturing problemsLeads and supports technology transfer (TT) across multiple unit operationCoordinates, plans, and executes manufacturing process validation runsSupports design and leads generation of sampling plans for process validation reports (PVRs) and investigationsWrites and reviews master batch records (MBRs) and standard operating procedures (SOPs), as neededGenerates and executes process training and consults on topics related to manufacturing and processLeads technical risk assessments for new manufacturing processesContributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verificationWrites documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments etc.Leads training of manufacturing staff and process sciences group on new processes, procedures, and use of equipment in the labInterprets and utilizes new knowledge to promptly drive data-based decisionsCollaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor supportLeads continuous improvement projects within unit operations, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and costSupports supplier technical evaluations, risk assessments, and raw material evaluation and qualificationOther duties, as assignedKnowledge and Skills
Proficient knowledge in Design of Experience (DOE)Proficient knowledge in Statistical Process ControlEffective communication, both written and oralAbility to effective present information to othersProficient project management skillsAdvanced problem-solving skillsAbility to provide feedback to others, including leadersAbility to develop effective working relationships internally and externallyAbility to adapt communication style to differing audiences and advise others on difficult mattersBasic Requirements
Associate degree in Engineering, Life Science or Chemical Engineering with 8 years related work experience (e.g., manufacturing); or Bachelor’s degree in in Engineering, Life Science or Chemical Engineering with 6 years of related work experience (e.g.,manufacturing)Master’s degree with 3 years of related work experience; orPhD with no prior experienceLarge scale manufacturing experience with CHO cell processes/monoclonal antibody productionExperience quality systems (e.g., deviation management system, change control, CAPA, document management system)usingExperience using risk management and RCA tools
Preferred Requirements
Experience in contract manufacturing or interacting with contract manufacturersExperience working in a Good Manufacturing Practices (GMP) environment Prior drug substance and manufacturing experience, includingprocess development, validation, and transfer
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes
Ability to sit for prolonged periods of time. X No Yes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes
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.
EEO InformationFujifilm is committed to 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 (FDBN_PNC@fujifilm.com).
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