Scientist , QC Microbiology; Drug Product & Raw Materials

Position Overview

The Scientist 1, QC Microbiology, DP & RM, effectively and efficiently manages complex or difficult tasks with expertise within the assigned disciplines. This role initially supports the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments is required.

• Performs raw material microbial assessments, identifies requirements and executes actions as part of change control process
• Performs high throughput, right-first time work to meet production schedules and project milestones with minimal/no supervision
• Implements new raw materials, including specification authoring, requesting LIMS builds, assessing changes etc.
• Supports raw material life cycle management (new material assessment, specification establishment, maintenance of specifications etc.)
• Coordinates and is responsible for raw material data review and release for the Microbiology team
• Acts as subject matter experts for both raw materials and drug product manufacturing support
• Initiates qualification and study directed testing activities in support of Drug Product manufacturing
• Initiates technical writing initiatives and promotes problem-solving skills among the team
• Reviews and evaluates advanced lab testing results both internally and from third party laboratories
• Performs testing and review of QC samples
• Serves as point of contact to third party laboratories
• 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
• Provides OOS investigational support, as needed
• Supports laboratory management and mentors another 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
• Performs other duties, as assigned

• Bachelor’s degree in chemistry, biochemistry, microbiology or other relevant scientific discipline with 6 years’ experience OR
• Master’s degree in chemistry, biochemistry, microbiology or other relevant scientific discipline with 3 years’ experience OR
• PhD with 1 year of applicable industry experience
• 1-3 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
• LIMS experience
• Experience with document control including writing and editing technical documents and presentations

• Knowledge in Microbiology theory
• Knowledge of Microbiology testing and laboratory experience, specific to both drug product manufacturing support and raw materials testing

Ability to discern audible cues. Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. 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 wrists, 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 warm/cold environments (5

C). Will work in small and/or enclosed spaces. Specific to both drug product manufacturing
support and raw materials testing.

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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 ().