The Scientist 1, QC Microbiology (Drug Product & Raw Materials) supports a broad range of microbiological functions for both raw materials and drug product manufacturing support. This role manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory in support of these two areas. This role follows procedures and has mastery of a wide variety of microbiological methods specific to raw material and drug product manufacturing and supporting data management processes. The Scientist 1, QC Microbiology (DP and 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 are required.

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

What You'll Do

• 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’ 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
• Performs other duties, as assigned

Minimum Requirements:

• 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 Requirements:

• 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

Physical and Work Environment Requirements:

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.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

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 (FDBN_PNC@fujifilm.com).