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FUJIFILM Cellular Dynamics, Inc · 2 weeks ago

Scientist 1, QC Microbiology

US-NC-Holly Springs

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 supports microbiological functions for raw materials and drug product manufacturing, managing complex tasks and ensuring compliance with quality standards.

BiotechnologyHealth CareManufacturingPharmaceutical

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

Microbiology testingGMP complianceLIMS experienceDocument controlInvestigations trainingLEAN principlesSix Sigma principlesMicrobiology theoryMentoring 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 Cellular Dynamics, Inc

Fujifilm Cellular Dynamics, Inc. develops and manufactures biologically relevant human cells derived from induced pluripotent stem (iPS) cells.

Founded in 2004

Madison, Wisconsin, USA

51-200 employees

https://www.fujifilmcdi.com

H1B Sponsorship

FUJIFILM Cellular Dynamics, Inc 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

Represents job field similar to this job

Trends of Total Sponsorships

2023 (4)

2021 (1)

2020 (3)