Senior Analyst 1, QC Analytical Development Bioassay

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The Senior Analyst 1 QC Analytical Development (QCAD) Bioassay supports the implementation of plate and cell-based analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Holly Springs. This role supports the transfer and validation of methods such as residuals (HCP DNA Protein A) dot blot for product identity ELISA ID/ Potency and various cell-based assays. The Senior Analyst 1 QC AD Bioassay ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and author and review procedures SOPs and technical reports.

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 analytical method transfers and validations for plate and cell-based Bioassays for the QC Analytical Development team.
Ensures compliance of analytical testing with appropriate GMP regulations.
Participates in regular meetings for TT programs with cross-functional teams and key stakeholders.
Authors and reviews SOPs protocols and technical reports.
Works cross-functionally with Contract Laboratory Organizations (CLOs) QC testing teams Quality Assurance (QA) and Process Science groups to ensure transfer of methods according to deadlines.
Collaborates with the LIMS team and IT department to build new analytical method functionality that meets end-user and customer requirements.
Ensures compendial method oversight and scientific guidelines (e.g. ICH EMA FDA etc.).
Supports regulatory requests and inspections.
Supports the QCAD team to investigate any project challenges with necessary risk assessment tools and techniques as needed.
Supports best practices for TT and PPQ strategies globally as required.
Coordinates and supports QCAD Bioassay lab activities and provide training for QC Bioassay lab technicians.
Performs other duties as assigned.

Minimum Qualifications

Bachelors Degree in Microbiology Virology Biology Biological Sciences Engineering or related science field with 2 years of analytical laboratory experience preferably in Biotechnology Pharma Contract Research Organization (CRO) or Contract Laboratory Organization (CLO); OR
Masters Degree in Virology Microbiology Biology or related science field with Microbiology Virology Biology Biological Sciences Engineering or related science field with 0 years of previous experience.
1 years of experience in a GMP environment.
Experience with QC Bioassay testing methods including protein binding assays (e.g. ELISA Dot Blot etc.).
Experience with analytical method development tech transfers and validation residual testing for DNA Host Cell Protein (HCP) Protein A.

Preferred Qualifications

Masters in Virology Microbiology Biology or related science field with 1 years of related experience.
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 ascend or descend ladders scaffolding ramps etc.
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 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 small and/or enclosed spaces.
Will work in heights greater than 4 feet.

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 Analytical Development (QCAD) Bioassay supports the implementation of plate and cell-based analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Holly Spr...