Job Description

About the Role

The Raw Materials QC Manager is accountable for GMP compliant laboratory operations according to GMP guidelines. This role is responsible for direct management and supervision of the QC Raw Materials teams performing raw material testing according to USP/EP/JP guideline and releasing raw materials for use in the drug substance and drug product manufacturing process. The Manager, QC Raw Materials is responsible for managing raw material specifications, handling changes from customers on customer owned materials as well as handling and implementing new raw materials and consumables as part of tech transfer activities. In addition, the QC Raw Materials team is responsible for testing, disposition, and release of raw materials and Trackwise support or investigation of deviations including Out of Specification (OOS) results. Provide managerial support for troubleshooting of complex investigations and optimizing laboratory systems. Ensure that the laboratory is maintained in a state of GMP compliance. All documentation is in accordance with GMP and all reported results are accurate. The Manager, QC Raw Materials is the technical subject matter expert (SME) and participates in assessing the testing of raw materials and excipients, represents the QC Raw Materials team during regulatory and customer audits. The Manager models leadership competencies and aids in the development of QC team members.

Responsibilities

• Ensures GMP compliant laboratory operations according to guidelines
• Manages the daily activities of the QC Raw material team and assuring dedicated focus on testing, release, change management and Tech Transfer activities in support of new and existing customer programs
• Ensures overall performance of QC Raw Material team according to KPIs. Assures turn-around-times of all testing, raw material approvals and supporting drug substance and drug product manufacturing production.
• Oversees and manages laboratory exceptions and investigations and assures timely closure of cGMP KPI deliverables within the group
• Motivates the group to perform as efficiently as possible to reduce turn-around-times for testing, approval and ensures manufacturing is running and tech transfer activities timelines are met
• Authors procedures, documents and reports, as needed, to support the QC Raw Materials team and tech transfer activities
• Leads projects for tech transfers by having dialogues with customers around customer owned and FDB owned materials, etc.
• Prioritizes and focuses on optimized laboratory systems, including the use of IT systems (e.g. Labware), identifies and implements needed procedural and/or policy changes in areas where needed. Enforces established policies, processes and procedures and identifies areas where enhancements will improve daily work
• Leads cross-functional collaboration with QC Analytical Development, QC Program Management, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives
• Authors, reviews, and approve data reports, out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls, as needed
• Ensures the team and laboratory maintains inspection readiness for customer visits, audits and regulatory inspections following cGMP guidelines and FUJIFILM Diosynth Biotechnologies processes
• Ensures the timely delivery of results within deadlines by effectively managing the performance of the QC Raw Material Team
• Represents QC in relevant internal and external cross-functional meetings and projects to ensure delivery of QC Raw Material objectives
• Executes managerial tasks per the FUJIFILM Diosynth Biotechnologies policies including coaching, guidance, and development of team members
• Supports management activities related to compliance with policies, appropriate personnel training, providing feedback for personnel development, and effective and timely decision making/corrective actions on the floor

Qualifications

• Bachelor’s degree with 8+ years of experience in a GMP environment OR
• Master’s Degree with 6+ years of experience in GMP environment OR
• Ph.D. with 4+ years of experience in GMP environment
• 5+ years of experience with analytical testing, preferably raw material testing and release
• Previous QC Raw Materials Management experience

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