Scientist 1, QC Compendial Testing

Position Overview

The Scientist 1, QC Compendial Testing participates in the Technology Transfer (TT) of material methods into the FUJIFILM Biotechnologies, Holly Springs Quality Control Laboratory, with limited supervision. This includes the onboarding of new and generic raw materials as part of new customers/programs. This role provides assessments, identifies QC compendial testing requirements and executes action items as part of change controls for the onboarding of these materials based on vendor documentation. This position also identifies materials together with customers in a cross functional team as well as provides technical knowledge to assess testing approach, verification and validation needs both internally and at external contract labs. Following TT activities, the role performs release testing using the established analytical methods.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do

• Performs as a subject matter expert (SME) in the designated methods transferred into FUJIFILM Biotechnologies, Holly Springs.
• Coordinates, ensures, and performs release/sampling and chemical analysis of materials; prepares monthly metrics for material release, as needed.
• Represents QC Compendial Testing on internal and external TT meetings related to new products.
• Performs material assessments, identifies requirements and executes actions as part of change control process and vendor change notifications.
• Initiates, executes and approves Trackwise deviations, CAPAs, lab exceptions and invalid assays.
• Ensures QC Compendial Testing team is on track for internal verification/testing and timelines align with TT project timelines.
• Coordinates QC Compendial Testing and Drug Product activities (i.e., transfer plans, validation/verification/transfer protocols and reports, justification specification and transfer summary reports and change control assessments).
• Creates meeting agenda and minutes, hosts and facilitates meetings, manages the raw material and drug product method portfolio and provides progress updates to stakeholders.
• Supports maintenance of effective laboratory systems, ensuring integrity of all laboratory results.
• Enforces established policies and procedures and identifies areas where enhancements will improve daily work.
• Leads and coordinates implementation of new technologies.
• Uses in-depth technical knowledge of Chemistry to author and review procedures, protocols and reports where necessary.
• Supports material life cycle management (new material assessment, specification establishment, maintenance of specifications, etc.) and implements new materials, including authoring specifications, requesting laboratory information management system (LIMS) builds, assessing changes, etc.
• Ensures compliance with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP); provides reports for review in a timely manner; participates in audits and inspections.
• Maintains adequate inventory of supplies needed for all raw material sampling including but not limited to pipettes, containers and consumables.
• Reports excursion/Out-of-Specifications (OOS) results to the Manager, QC Compendial Testing.
• Provides OOS investigational support, as needed.
• Performs other duties, as assigned.

Knowledge, Skills, and Abilities

• Extensive technical chemical (or protein) knowledge.
• Good computer skills; excellent analytical skills and ability to analyze raw data, assess assay and system suitability criteria.
• Capability to absorb and utilize new knowledge in a fast-paced environment; ability to prioritize and adapt to business needs.
• Ability to work in a team and as an individual; project management skills.
• Excellent ability to multi-task, plan, prioritize and follow-through on one’s work and the work of others.
• Good understanding of GMP/GLP guidelines.
• Strong customer focus; excellent verbal and written communication skills.

Minimum Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline with 5 years of applicable industry experience; OR,
• Master’s degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline with 3+ years of applicable industry experience; OR,
• D. in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline with no years of experience.
• Experience with compendial testing methodology as it pertains to cGMP.
• Experience with method transfers.

Preferred Qualifications

• 3+ years of experience working in a regulated GMP environment.
• Experience in assay troubleshooting and problem solving.
• Experience with Trackwise.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.  While performing the duties of this job, the employee is required on a regular basis to:

• 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 for up to 240 minutes.
• Ability to sit for prolonged periods of time for up to 240 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.
• 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.

*LI-Onsite

EEO Information

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.

ADA Information

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 ([email protected]).