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FUJIFILM Biotechnologies · 2 weeks ago

Scientist 1, QC Microbiology

Holly Springs, NC

Full-time

Onsite

Mid, Senior Level

3+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Scientist 1, QC Microbiology role supports microbiological functions for raw materials and drug product manufacturing, managing multiple assignments and ensuring compliance with cGMP standards.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Performs non-routine complex testing, identifies requirements and executes actions as part of change control process. Assists and guides others in the lab with routine testing

Performs high throughput, right-first time work to meet production schedules and project milestones with minimal/no supervision

Leads qualification and study directed testing activities

Reviews and evaluates advanced lab testing results

Acts as a qualified trainer and Subject Matter Expert (SME) of multiple tests

Authors, reviews, and edits documents and study protocols

Supports intermediate investigations of OOS assays and events

Ensures compliance with cGMP and participates in audits and inspections

Supports laboratory management and mentors’ others on the team, as needed

Leads LEAN lab and six sigma principles and applies them to laboratory processes

Acts as project leader for projects in the lab and department

Leads audit readiness and participates/supports for the team

Performs other duties, as assigned

Qualification

MicrobiologyGMPLIMSDocument controlLEAN/6SInvestigations trainingSoft skills

Required

Bachelor's degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 5+ years' experience OR

Master's degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 3+ years' experience OR

PhD with 1+ years of applicable industry experience

3+ years of experience working in a regulated GMP environment

Expert understanding of GMP, GLP, GDP requirements

Experience and proficient knowledge in Microbiology theory

Experience and proficient knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing support and raw materials testing

Advanced LIMS experience

Advanced experience with document control including writing and editing technical documents and presentations

Preferred

SME level knowledge in Microbiology theory

SME level knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing support and raw materials testing

Investigations training (Trackwise or similar)

LEAN/6S certification

Familiarity with global regulatory guidelines and testing implications

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)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2021 (1)