Analyst, Quality Control Bioassay

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The Quality Control Bioassay Analyst works with direction from manager to execute QC cell- and plate-based analytical methods including protein binding assays cell-based potency assays cell culture routine maintenance and residual testing for DNA Host Cell Protein (HCP) Protein A/G. The QC Bioassay Analyst adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identify laboratory exceptions invalid assays deviations change controls and corrective and preventative actions (CAPAs). The QC Bioassay Analyst is primarily responsible for executing routine analytical methods in support of manufacturing and as needed supporting laboratory execution of analytical method transfers and validations. The ability to effectively communicate and function in a fast-paced highly technical environment is essential to success.

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 cell- and plate-based analytical methods including protein binding assays (e.g. ELISA Dot Blot etc.) cell-based potency assays cell culture maintenance and residual testing for DNA Host Cell Protein (HCP) Protein A/G
Ensures analytical testing of in process drug substance (DS) drug product (DP) and stability samples are 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 Bioassay
Identifies and follows-up on excursions and deviations and initiate corrective and preventative actions (CAPAs)
Coordinates and supports QC Bioassay lab activities as needed.
Supports laboratory execution of analytical method transfers and validations
Assists with authoring and reviewing QC SOPs.
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 Requirements:

Bachelors degree in life sciences Virology Biology Chemistry Biochemistry or related science field with 0 - 2 years of experience
0-2 years GMP laboratory experience

Preferred Requirements:

Experience with LIMS software

Working Environment Physical Demands:

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 work that includes moving objects up to 10 pounds.

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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.

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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:

Position OverviewThe Quality Control Bioassay Analyst works with direction from manager to execute QC cell- and plate-based analytical methods including protein binding assays cell-based potency assays cell culture routine maintenance and residual testing for DNA Host Cell Protein (HCP) Protein A/G....