Scientist 1, QC Microbiology (Drug Product & Raw Materials)

The Scientist 1 QC Microbiology (Drug Product & Raw Materials) supports a broad range of microbiological functions for both raw materials and drug product manufacturing support. This role manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory in support of these two areas. This role follows procedures and has mastery of a wide variety of microbiological methods specific to raw material and drug product manufacturing and supporting data management processes. The Scientist 1 QC Microbiology (DP and RM) effectively and efficiently manages complex or difficult tasks with expertise within the assigned disciplines. This role initially supports the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments are required.

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

Performs raw material microbial assessments identifies requirements and executes actions as part of change control process
Performs high throughput rightfirst time work to meet production schedules and project milestones with minimal/no supervision
Implements new raw materials including specification authoring requesting LIMS builds assessing changes etc..
Supports raw material life cycle management (new material assessment specification establishment maintenance of specifications etc.)
Coordinates and is responsible for raw material data review and release for the Microbiology team
Acts as subject matter experts for both raw materials and drug product manufacturing support
Initiates qualification and study directed testing activities in support of Drug Product manufacturing
Initiates technical writing initiatives and promotes problemsolving skills among the team
Reviews and evaluates advanced lab testing results both internally and from third party laboratories
Performs testing and review of QC samples
Serves as point of contact to third party laboratories
Authors reviews and edits documents and study protocols
Supports intermediate investigations of OOS assays and events
Ensures compliance with cGMP and participates in audits and inspections
Provides OOS investigational support as needed
Supports laboratory management and mentors others on the team as needed
Leads LEAN lab and six sigma principles and applies them to laboratory processes
Acts as project leader for projects in the lab and department
Performs other duties as assigned

Minimum Requirements:

Bachelors degree in chemistry Biochemistry Microbiology or other
relevant scientific discipline with 5 years experience OR
Masters degree in chemistry Biochemistry Microbiology or other
relevant scientific discipline with 3 years experience OR
PhD with 1 years of applicable industry experience
3 years of experience working in a regulated GMP environment
Expert understanding of GMP GLP GDP requirements
Experience and proficient knowledge in Microbiology theory
Experience and proficient knowledge of Microbiology testing and
laboratory experience specific to both Drug product manufacturing
support and raw materials testing.
Advanced LIMS experience
Advanced experience with document control including writing and
editing technical documents and presentations

Preferred Requirements:

SME level knowledge in Microbiology theory
SME level knowledge of Microbiology testing and laboratory experience specific to both Drug product manufacturing support and raw materials testing

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 60 minutes.

Ability to sit for prolonged periods of time up to 60 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 ().