Scientist 1, QC Microbiology (Drug Product & Raw Materials)

FUJIFILM Diosynth Biotechnologies; Holly Springs (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

Join a forward-thinking company at the forefront of biopharmaceutical manufacturing. As a Scientist 1 in QC Microbiology, you will play a crucial role in ensuring the quality of raw materials and drug products. This position offers an exciting opportunity to work in a state-of-the-art facility, where you will manage microbial assessments, support lifecycle management, and lead initiatives in a collaborative environment. With a commitment to innovation and excellence, this role is perfect for those passionate about making a difference in the life sciences industry. Your expertise will help shape the future of healthcare solutions.

Qualifications

• 5+ years of experience in a GMP environment with a Bachelor's degree.
• SME level knowledge in Microbiology theory and testing.

Responsibilities

• Perform microbial assessments and manage change control processes.
• Lead technical writing and promote problem-solving in lab projects.
• Ensure cGMP compliance and participate in audits.

Skills

Microbiology

cGMP Compliance

Technical Writing

LEAN and Six Sigma

Data Management

Education

Bachelor's degree in Chemistry, Biochemistry, or Microbiology

Master's degree

PhD

Tools

LIMS (Laboratory Information Management System)

Job description

Scientist 1, QC Microbiology (Drug Product & Raw Materials)

Join to apply for the Scientist 1, QC Microbiology (Drug Product & Raw Materials) role at FUJIFILM Diosynth Biotechnologies.

The Scientist 1, QC Microbiology supports microbiological functions for raw materials and drug product manufacturing. Responsibilities include managing multiple assignments, following procedures, mastering microbiological methods, and supporting data management. The role involves supporting commissioning activities for a new biopharmaceutical facility and requires flexibility.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO. We are expanding and looking for passionate, mission-driven individuals to help manufacture vaccines, cures, or gene therapies. Join us and be part of a culture that fuels your passion and energy.

Join us

We are investing over $2 billion in a new large-scale biopharmaceutical manufacturing site in Holly Springs, North Carolina, to become North America's largest end-to-end cell culture CDMO provider, offering comprehensive manufacturing and support services.

Job Description

What You'll Do

• Perform raw material microbial assessments and manage change control processes.
• Execute high throughput work to meet schedules with minimal supervision.
• Implement new raw materials, including specifications and LIMS requests.
• Support raw material lifecycle management.
• Review and release raw material data for microbiology.
• Act as subject matter expert for raw materials and drug product support.
• Initiate qualification and testing activities for drug manufacturing.
• Lead technical writing and promote problem-solving.
• Evaluate lab testing results internally and from third-party labs.
• Perform QC testing and review samples.
• Coordinate with third-party labs.
• Author and review documents and protocols.
• Support investigations of OOS assays.
• Ensure cGMP compliance, participate in audits.
• Provide investigational support for OOS events.
• Mentor team members and support laboratory management.
• Lead LEAN and Six Sigma initiatives.
• Lead projects within the lab and department.

Minimum Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Microbiology, or related field with 5+ years’ experience OR
• Master’s degree with 3+ years’ experience OR
• PhD with 1+ years’ experience, plus 3+ years’ experience in a GMP environment.

Preferred Requirements

• SME level knowledge in Microbiology theory and testing.

Physical and Work Environment

Must be able to discern audible cues, inspect with corrected vision, stand/sit for extended periods, perform repetitive motions, lift up to 10 pounds, and work in various environments.

Please note: No phone calls or emails to FUJIFILM employees. All submissions by search firms must have a valid agreement. FUJIFILM is an equal opportunity employer and provides accommodations upon request.