Scientist 1 Global QC Raw Materials Microbiology

The Scientist 1 Global QC Raw Materials (Microbiology) liaises with various external collaborators contract laboratory organizations QC testing teams and QA groups to ensure training needs internal procedures specifications and protocols are met. This role ensures compliance with the pharmacopoeias and
ICH guidelines. This role generates protocols and reports to support tech transfer activities and performs change control assessment activities for tech transfers to include implementation of new raw materials new test laboratories specifications updates e.g. new methods and new vendors.

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

Supports RM tech transfer activities by implementing methods for Bioburden Endotoxin and Identification of bacteria species either internally at FDB or at external CLOs
Performs troubleshooting in close collaboration with FDB or external CLOs to ensure suitable methods can be implemented
Authors protocols and reports for proving method suitability for internal FDB methods according to compendial requirements
Reviews and approves external protocols and reports for proving method suitability for CLO methods according to compendial requirements
Participates in internal and external investigations as SME to ensure compliance with FDB processes for deviations or out of specifications (OOS)
Author strategy documents and updates relevant SOPs
Oversees compendial methods and scientific guidelines e.g. ICH EMA FDA etc
Performs other duties as assigned

Minimum Requirements:

Bachelors Masters in chemistry Biochemistry Microbiology or
other relevant scientific discipline with 5 years experience OR
Masters in chemistry Biochemistry Microbiology or other relevant scientific discipline with 3 years experience OR
PhD with 1 years of applicable industry experience
4 years of experience in a federally regulated GMP environment
Experience with method transfers
Indepth knowledge of Raw Material methodology as it pertains to cGMP

Preferred Requirements:

Indepth knowledge of Raw Material methodology as it pertains to cGMP

Physical and Work Environment Requirements:

Ability to discern audible cues.

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

Ability to stand for prolonged periods of time up to 240 minutes.

Ability to sit for prolonged periods of time up to 240 minutes.

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

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

Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions.

Will work in warm/cold environments 5 C)

Will work in small and/or enclosed spaces.

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 ().