Scientist II Analytical Development Tech Transfer

The Analytical Development (AD) Tech Transfer (TT) Scientist 2 manages and coordinates the transfer of drug substance and drug product QC analytical methods from customers into the largescale manufacturing facility from first campaign through commercialization (clinical through process performance qualification/commercial). This role interfaces with customers and crossfunctional teams to scope analytical testing plans and achieve project milestones. This role authors/reviews transfer plans method transfer documents transfer summary reports and specification justification reports as needed. This role effectively communicates and operates between different teams ensuring compliance with regulations and optimizing processes for efficient transfer of knowledge and technology.

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

Minimum Requirements:

B.S. in Chemistry Biochemistry Biological Sciences Engineering or related science field with 9 years of analytical laboratory experience preferably in biotechnology Pharma Contract Research Organization (CRO) or Contract Laboratory Organization (CLO)
46 years experience in a GMP environment

Preferred Requirements:

M.S. in Chemistry Biochemistry Biological Sciences Engineering or related science field with 7 years of experience OR
Ph.D. in Chemistry Biochemistry Biological Sciences Engineering or related science field with 5 years of experience
Experience with Customer Relationship Management
Prior drug substance or manufacturing experience including process validation transfer commercialization and manufacturing support and troubleshooting
Experience using quality systems (e.g. deviation management system change control corrective and preventive action (CAPA) document management system)

Physical and Work Environment Requirements:

Will work in environment which may necessitate respiratory protection

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color.

Abiltiy to stand for prolonged periods of time up to 120 minutes

Abiltiy to sitfor prolonged periods of time up to 120 minutes

Ability to conduct activities using repetitive motions that include writs hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Will work in warm/cold environments

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 .