Scientist 2, QC Microbiology (Drug Product & Raw Materials)

Fujifilm

Posted on : 02-08-2025

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1 Vacancy

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Job Location

Holly Springs, MS - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 02-08-2025

Job Description

Position Overview

The Scientist 2 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 & 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.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

What Youll Do

Performs raw material microbial assessments identifies requirements and executes actions as part of change control process
Performs high throughput right-first 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 problem-solving 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 8 years experience OR
Masters degree in chemistry Biochemistry Microbiology or other
relevant scientific discipline with 6 years experience OR
PhD with 4 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 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 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.

EEO Information

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.

ADA Information

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

Employment Type

Unclear

Company Industry

Department / Functional Area

Quality Control

Key Skills

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About Company

Fujifilm

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Scientist 2, QC Microbiology (Drug Product & Raw Materials)

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Department / Functional Area

Key Skills

About Company

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