Scientist 2 Lab

The Engineer/Scientist 2 will provide technology transfer support and technical oversight during manufacturing operations.

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 newlargescale 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 endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll Do

• Leads and supports technology transfer (TT) subteam activities by conducting lab and pilot plant experiments
• Collaborates and leads of sampling protocols as directed
• Participates in writing and reviewing master batch records (MBRs) and standard operating procedures (SOPs)
• Supports training of manufacturing staff
• Supports training members of the process sciences group on the use of equipment in the lab and pilot plant areas
• Analyzes and summarizes lab data for clients
• Writes process performance qualification (PPQ) protocols and reports
• Supports and leads TT within unit operation as directed
• Interprets and communicates results to the TT team
• Provides technical support for troubleshooting process assessments and of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to process deviations
• Writes reports and aids in closing out deviations
• Provides process training and consultation on topics related to manufacturing and process
• Provides input to technical risk assessments for new manufacturing processes
• Contributes to the management of manufacturing data (i.e. databasing) and the statistical analysis aimed at process monitoring and resolution of investigations
• Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns including onfloor support
• Supports continuous improvement projects in partnership with manufacturing when applicable to improve manufacturability reliability yield and cost
• Manages lab equipment
• Collaborates with colleagues to develop lab scale protocols
• Executes and oversees sampling plans for lab runs
• Serves as oncall for lab issues and concerns
• Other duties as assigned

Knowledge and Skills

• Ability to develop effective working relationships internally and externally
• Effective communication both written and oral
• Ability to provide feedback to others including leaders
• Strong problemsolving skills
• Project management skills
• Ability to effectively present information to others
• Ability to provide standard professional advice and to create reports and analyses for review

Basic Requirements

• Associate degree in Engineering Life Science or Chemical Engineering with 4 years of related work experience (e.g. manufacturing); or
• Bachelors degree in Engineering Life Science or Chemical Engineering with 2 years of related work experience (e.g. manufacturing); or
• Masters degree with no prior experience
• Experience using quality systems (e.g. deviation management change control CAPA document management system)

Preferred Requirements

• Experience working in a Good Manufacturing Practices (GMP)
  environment

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 viaemail 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.

Fujifilm 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.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .