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FUJIFILM Biotechnologies · 1 week ago

Sr. Analyst 1, QC Analytical Development Bioassay

Holly Springs, NC

Contract

Onsite

Mid, Senior Level

2+ years exp

FUJIFILM Biotechnologies is seeking a Sr. Analyst 1 for their QC Analytical Development Bioassay team. This role involves supporting the implementation and validation of analytical methods for drug substance and product, ensuring compliance with GMP regulations, and collaborating with various teams to facilitate method transfers.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

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

Qualification

GMP complianceAnalytical method developmentQC Bioassay testingLIMS softwareTechnical report writingRisk assessmentCross-functional collaboration

Required

B.S. 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)

M.S. 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' 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

Master's in Virology, Microbiology, Biology or related science field with 1+ years of related experience

Experience with LIMS software

Company

FUJIFILM Biotechnologies

Glassdoor3.4

For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.

Founded in 2011

Morrisville, North Carolina, USA

1001-5000 employees

https://fujifilmbiotechnologies.fujifilm.com/

H1B Sponsorship

FUJIFILM Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2021 (1)