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Lab Scientist 3

2 months ago

Holly Springs, United States FUJIFILM Holdings America Corporation Full time
Overview

The Scientist 3 will provide technology transfer support and technical oversight during manufacturing operations. The initial focus will be Process Science Laboratory operational readiness.

External US

Major Accountabilities

Conducts lab and pilot plant experiments
Generates and coordinates execution sampling protocols
Serves 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 deviations
Executes and analyzes lab and pilot plant work aimed at solving complex manufacturing problems
Leads and supports technology transfer (TT) across multiple unit operation
Coordinates, plans, and executes manufacturing process validation runs
Supports design and leads generation of sampling plans for process validation reports (PVRs) and investigations
Writes and reviews master batch records (MBRs) and standard operating procedures (SOPs), as needed
Generates and executes process training and consults on topics related to manufacturing and process
Leads technical risk assessments for new manufacturing processes
Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and
continued process verification
Writes 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 lab
Interprets and utilizes new knowledge to promptly drive data–based decisions
Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on–floor support
Leads continuous improvement projects within unit operations, in partnership with manufacturing when applicable, to improve manufacturability,
reliability, yield and cost
Supports supplier technical evaluations, risk assessments, and raw material evaluation and qualification
Other duties, as assigned

Minimum 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; or
PhD with no prior experience
Experience using quality systems (e.g., deviation management
system, change control, CAPA, document management system)
Experience using risk management and RCA tools

Preferred Requirements

Experience working in a Good Manufacturing Practices (GMP)
environment
Prior drug substance and manufacturing experience, including
process development, validation, and transfer

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 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 Range (If yes, specify approximate temperature ranges.)
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