Manager, QC Chemistry

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 the Role

 

The Manager, QC Chemistry is accountable for GMP compliant laboratory operations according to GMP guidelines. This role is responsible for direct management and supervision of the QC Chemistry team performing Chemistry and Chromatography testing for in process, drug substance, drug product and stability testing for the manufacturing of Biologics.

 

In addition, the QC Chemistry team performs TOC, nitrate, and conductivity testing for Utility Monitoring samples. The Manager, QC Chemistry is responsible for managing day-to-day activities including delivering on-time results for methods including: compendial, chromatography, spectroscopy, protein concentration, chemical analysis of stability samples, glycan analysis and wet lab chemistry.

This role provides managerial support for troubleshooting of complex investigations and optimizing laboratory systems. The position ensures 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 Chemistry is the technical subject matter expert (SME), represents the QC Chemistry team during regulatory and customer audits, and models leadership competencies and aid in the development of QC team members. The QC Chemistry team is responsible for executing the following analytical methods: chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance.

 

What You'll Do

 

• Ensures GMP compliant laboratory operations according to guidelines• Manages the daily activities of the QC Chemistry team to support DS and DP Manufacturing Process, testing of stability samples, method transfers of client methods, and change management• Ensures overall performance of QC Chemistry team according to KPIs - assuring turn-around-times of all testing 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 and approval, ensure manufacturing is running and tech transfer activity timelines are met• Authors procedures, documents and reports, as needed, to support the QC Chemistry team and tech transfer activities• 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• Represents QC Chemistry in 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 approves data reports, out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls, as needed• Ensures the team and laboratory maintain inspection readiness for customer visits, au