Scientist 1, QC Compendial Testing

About the role

As a Scientist 1 in QC Compendial Testing, you will participate in the Technology Transfer (TT) of material methods into the FUJIFILM Biotechnologies Quality Control Laboratory in Holly Springs, with limited supervision. This includes onboarding new and generic raw materials for new customers and programs. You will assess QC compendial testing requirements, execute action items for change controls, and provide technical expertise to evaluate testing approaches, verification, and validation needs both internally and at external contract labs. Following TT activities, you will perform release testing using established analytical methods.

Responsibilities

• Serve as a subject matter expert (SME) for methods transferred into FUJIFILM Biotechnologies, Holly Springs.
• Coordinate, ensure, and perform release/sampling and chemical analysis of materials; prepare monthly metrics for material release as needed.
• Represent QC Compendial Testing in internal and external TT meetings related to new products.
• Perform material assessments, identify requirements, and execute actions as part of the change control process and vendor change notifications.
• Initiate, execute, and approve Trackwise deviations, CAPAs, lab exceptions, and invalid assays.
• Ensure the QC Compendial Testing team stays on track for internal verification/testing and aligns timelines with TT project schedules.
• Coordinate QC Compendial Testing and Drug Product activities, including transfer plans, validation/verification/transfer protocols and reports, justification specifications, and change control assessments.
• Create meeting agendas and minutes, host and facilitate meetings, manage the raw material and drug product method portfolio, and provide progress updates to stakeholders.
• Support the maintenance of effective laboratory systems, ensuring the integrity of all laboratory results.
• Enforce established policies and procedures and identify areas for enhancements to improve daily work.
• Lead and coordinate the implementation of new technologies.
• Use in-depth technical knowledge of Chemistry to author and review procedures, protocols, and reports where necessary.
• Support material life cycle management, including new material assessment, specification establishment, and maintenance of specifications.
• Implement new materials, including authoring specifications, requesting LIMS builds, and assessing changes.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP); provide reports for review in a timely manner and participate in audits and inspections.
• Maintain adequate inventory of supplies needed for raw material sampling, including pipettes, containers, and consumables.
• Report excursion/Out-of-Specifications (OOS) results to the Manager, QC Compendial Testing and provide OOS investigational support as needed.
• Perform other duties as assigned.

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
• Ph.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.

Skills

• 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.

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 to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Ability to discern audible cues.
• Ability to inspect or perform tasks with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of up to 240 minutes.
• Ability to sit for prolonged periods of 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.
• Work in warm/cold environments.
• Work in small and/or enclosed spaces.