Senior Analyst 1, QC Chemistry

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The Senior Analyst 1 QC Chemistry works with limited direction to execute QC Analytical Chemistry methods used in biological product manufacturing including chromatography spectroscopy electrophoresis wet chemistry glycan analysis sub-visible particle analysis peptide mapping and physical appearance etc. The Senior Analyst 1 QC Chemistry adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identifies laboratory exceptions invalid assays deviations change controls and corrective and preventative actions (CAPAs). The Senior Analyst 1 QC Chemistry is primarily responsible for executing routine analytical methods in support of manufacturing supporting laboratory execution of analytical method transfers and validations and training other QC Chemistry laboratory associates.

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

Executes physical and chemical analytical testing 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.
Ensures analytical testing of in-process drug substance (DS) drug product (DP) and stability samples is performed according to appropriate GMP regulations.
Ensures analytical testing data is captured in LIMS software and data integrity is maintained.
Reports assay performance and assists with implementing improvements that ensure quality and efficiency within QC Chemistry.
Identifies and follows up on excursions and deviations and initiates corrective and preventative actions (CAPAs).
Coordinates and supports QC Chemistry lab activities as needed.
Provides training for QC Chemistry lab associates.
Authors and reviews SOPs and technical reports.
Works cross-functionally with other QC departments Manufacturing Process Science and Quality Assurance stakeholders to achieve customer and FUJIFILM Biotechnologies objectives.
Performs other duties as assigned.

Minimum Qualifications

Bachelors Degree in Chemistry Biochemistry Biological Sciences Engineering or related science field with 3 years of experience 1- 3 years relevant experience.
3 years laboratory experience.
1-3 years GMP laboratory experience.
Experience with physical and chemical analytical testing 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 CE1SDS imaged capillary isoelectric focusing (icIEF)) wet chemistry glycan analysis sub-visible particle analysis peptide mapping and physical appearance etc.. with cellular and molecular analytical testing methods

Preferred Qualifications

Masters Degree in Chemistry Biochemistry Biological Sciences Engineering or related science field.
1 years of experience with Raw Material methodology as it pertains to cGMP.
Experience with LIMS software.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job the employee is required on a regular basis to:

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 wrist hands and/or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
Ability to bend push or pull and reach to retrieve materials from 18 to 60 in height and use twisting motions.
Will work in warm/cold environments.
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.

*LI-Onsite

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 ().

Required Experience:

Senior IC

Position OverviewThe Senior Analyst 1 QC Chemistry works with limited direction to execute QC Analytical Chemistry methods used in biological product manufacturing including chromatography spectroscopy electrophoresis wet chemistry glycan analysis sub-visible particle analysis peptide mapping and ph...