Upstream / Cell Culture Scientist 3 or Engineer 3
3 weeks ago
The Engineer/Scientist 3 will provide technology transfer support and technical oversight during manufacturing operations
External US
Major Accountabilities
Leads and supports Upstream / Cell Culture Technology transfer sub–team activitiesCollaborates and leads execution of sampling protocols, as directedParticipates in writing and reviewing master batch records (MBRs) and standard operating procedures (SOPs)Supports training of manufacturing staffSupports training members of the process sciences group on the use of equipment in the lab and pilot plant areasAnalyzes and summarizes lab data for clientsWrites process performance qualification (PPQ) protocols and reportsInterprets and communicates results to the TT teamProvides Upstream / Cell Culture technical support for troubleshooting, process assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to process deviationsWrites reports and aids in closing out deviationsProvides process training and consultation on topics related to manufacturing and processProvides input to technical risk assessments for new manufacturing processesContributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at process monitoring and resolution of investigationsCollaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on–floor supportSupports continuous improvement projects, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and costManages lab equipmentCollaborates with colleagues to develop lab scale protocolsExecutes and oversees sampling plans for lab runsServes as on–call for lab issues and concernsOther duties, as assignedMinimum Education and Experience RequirementsBachelor's degree in Life Science or Chemical Engineering with 6 years of relevant work experience ORMaster's degree with 3 of relevant work experience.Experience using quality systems (e.g., deviation management, change control, CAPA, document management system)Preferred RequirementsExperience working in a Good Manufacturing Practices (GMP) environmentPrior drug substance and commercial manufacturing experience, including late stage process development, validation, and tech transferFDBN 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 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.
PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
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
WORKING ENVIRONMENT
PHYSICAL DEMANDS
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
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments. X No Yes
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes
-
Engineer Upstream
4 weeks ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Engineer Upstream
3 weeks ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Senior Engineer, Process Development
3 weeks ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Senior Engineer, Process Development
1 month ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
Senior Engineer, Process Development
3 weeks ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
Senior Engineer, Process Development
1 month ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Associate Engineer
3 weeks ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Associate Engineer
4 weeks ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Senior Manager, Engineering Utilities
3 weeks ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Holly Springs, Georgia, United States FUJIFILM Full timeOverviewFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB 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...
-
Senior Manager, Engineering Utilities
3 weeks ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...
-
Supply Chain Program Lead 3
3 weeks ago
Holly Springs, Georgia, United States FUJIFILM Full timeOverviewThe Supply Chain Program Lead position is a key link between customers and the Supply Chain organization for FDBN. This role interfaces with externalcustomers for onboarding new programs and established programs. This position is responsible for all Supply Chain related functions while interactingwith customers to support tech transfer needs in the...
-
Supply Chain Program Lead 3
4 weeks ago
Holly Springs, Georgia, United States FUJIFILM Full timeOverviewThe Supply Chain Program Lead position is a key link between customers and the Supply Chain organization for FDBN. This role interfaces with externalcustomers for onboarding new programs and established programs. This position is responsible for all Supply Chain related functions while interactingwith customers to support tech transfer needs in the...
-
Engineering Intern
2 months ago
Holly Springs, Georgia, United States Magna International Inc. Full timeJob Number: 65726 Group: Magna Electronics Division: Magna Electronics Holly Job Type: Intern/Co-op Location: Grand Blanc, HOLLY Work Style: About usWe see a future where everyone can live and move without limitations. That's why we are developing technologies, systems and concepts that make vehicles safer and cleaner, while serving our communities, the...
-
Process Development Senior Scientist
4 weeks ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Process Development Senior Scientist
3 weeks ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Senior Engineer
3 weeks ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
Quality Assurance Specialist, PQS
7 days ago
Holly Springs, Georgia, United States Fujifilm Corporation Full timeOverview Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO The work we do at FDB 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...
-
Quality Engineer
6 days ago
Holly Springs, Georgia, United States Magna International Inc. Full timeAbout us We see a future where everyone can live and move without limitations. That's why we are developing technologies, systems and concepts that make vehicles safer and cleaner, while serving our communities, the planet and, above all, people. Forward. For all. Group Summary Magna Electronics leads the way in active safety technologies, revolutionizing...
-
Senior Engineer
55 minutes ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
