Manager, QC Raw Materials

Overview

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

The work we do at FDB 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 FDB 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.

External US

About This Role

 

The Manager, QC Raw Materials 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.

 

What You’ll Do

 

• • 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 Biotec