Scientist 1, QC Chemistry

Fujifilm

Posted on : 24-05-2025

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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 : 24-05-2025

Job Description

Position Overview

About the Role

The Scientist 1 QC Chemistry is responsible for QC analytical chemistry methods used in biological product manufacturing including chromatography (GC HPLC UPLC SEC) spectroscopy (MS GC/MS LC-MS/MS UV UV-Vis FTIR) electrophoresis (GE non-reducing and reducing CE-SDS imaged capillary isoelectric focusing (icIEF)) wet chemistry glycan analysis sub-visible particle analysis peptide mapping and physical appearance etc. The Scientist 1 QC Chemistry ensures GMP-compliant laboratory operations in accordance with regulatory guidelines. This role performs technical/compliance reviews and approves analytical results. The role approves laboratory exceptions invalid assays deviations change controls and corrective and preventative actions (CAPAs).

Company Overview

FUJIFILM Diosynth 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 physical and chemical analytical testing methods for biological products including chromatography (GC HPLC UPLC SEC) spectroscopy (MS GC/MS LC-MS/MS UV UV-Vis FTIR) electrophoresis (GE non-reducing and reducing CE-SDS imaged capillary isoelectric focusing (icIEF)) wet chemistry glycan analysis sub-visible particle analysis peptide mapping and physical appearance
Ensures analytical testing of in-process drug substance (DS) drug product (DP) and stability samples is performed according to appropriate GMP regulations
Performs laboratory work and peer reviews of analytical data in support of tech transfer and routine manufacturing
Executes and reviews method qualification and validation activities and maintains lab equipment
Monitors assay performance and implements improvements that ensure quality and efficiency within QC Chemistry
Troubleshoots and investigates deviations and invalid assays performed in QC Chemistry
Authors reviews and approves SOPs protocols reports change controls Trackwise deviations out-of-specification (OOS) and out-of-trend (OOT) investigations and CAPAs for the QC Chemistry team as needed
Participates in cross-functional collaborations with other QC Departments Manufacturing Process Science and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives
Manages and monitors lab activities as needed
Provides training for QC Chemistry associates
Provides technical support as the QC Chemistry SME during customer visits audits and regulatory inspections
Participates in risk and gap assessments during project scoping as needed
Collaborates with the LIMS team and IT department to build new method functionality that meets end-user and customer requirements
Liaises with Contract Laboratory Organizations (CLOs) to monitor method execution and the timely delivery of results as needed
Executes routine analytical methods and trains other QC Chemistry laboratory associates
Performs other duties as assigned

Minimum Requirements:

B.S. in Chemistry Biochemistry Biological Sciences Engineering or related science field with 5 years of experience OR
M.S. in Chemistry Biochemistry Biological Sciences Engineering or related science field with 3 years of experience OR

Ph.D. in Chemistry Biochemistry Biological Sciences Engineering or related science field with 1 years of experience
Analytical laboratory experience preferably in biotechnology Pharma Contract Research Organization (CRO) or Contract Laboratory Organization (CLO)
3 years of experience working in a regulated GMP environment
Knowledge and experience of physical and chemical analytical testing methods for biological products including chromatography (GC HPLC UPLC SEC) spectroscopy (MS GC/MS LC-MS/MS UV UV-Vis FTIR) electrophoresis (GE non-reducing and reducing CE-SDS imaged capillary isoelectric focusing (icIEF)) wet chemistry glycan analysis sub-visible particle analysis peptide mapping and physical appearance.

Preferred Requirements:

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:

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 ascend or descend ladders scaffolding ramps etc.

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.

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 (5C).

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 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.

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 1, QC Chemistry

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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