Scientist 1, QC Compendial Testing

Job Description

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.

What You’ll Do

\n
• Performs as a subject matter expert (SME) in the designated methods transferred into FUJIFILM Biotechnologies, Holly Springs.
\n
• Coordinates, ensures, and performs release/sampling and chemical analysis of materials; prepares monthly metrics for material release, as needed.
\n
• Represents QC Compendial Testing on internal and external TT meetings related to new products.
\n
• Performs material assessments, identifies requirements and executes actions as part of change control process and vendor change notifications.
\n
• Initiates, executes and approves Trackwise deviations, CAPAs, lab exceptions and invalid assays.
\n
• Ensures QC Compendial Testing team is on track for internal verification/testing and timelines align with TT project timelines.
\n
• 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).
\n
• Creates meeting agenda and minutes, hosts and facilitates meetings, manages the raw material and drug product method portfolio and provides progress updates to stakeholders.
\n
• Supports maintenance of effective laboratory systems, ensuring integrity of all laboratory results.
\n
• Enforces established policies and procedures and identifies areas where enhancements will improve daily work.
\n
• Leads and coordinates implementation of new technologies.
\n
• Uses in-depth technical knowledge of Chemistry to author and review procedures, protocols and reports where necessary.
\n
• 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.
\n
• 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.
\n
• Maintains adequate inventory of supplies needed for all raw material sampling including but not limited to pipettes, containers and consumables.
\n
• Reports excursion/Out-of-Specifications (OOS) results to the Manager, QC Compendial Testing.
\n
• Provides OOS investigational support, as needed.
\n
• Performs other duties, as assigned.
\n

Knowledge, Skills, and Abilities

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

Minimum Qualifications

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

Preferred Qualifications

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