QC Chemistry Manager

1 week ago


Holly Springs, North Carolina, United States FUJIFILM Corporation Full time
About the Role

The Manager, QC Chemistry is a critical position responsible for ensuring GMP compliant laboratory operations according to guidelines. This role oversees the daily activities of the QC Chemistry team, supporting drug substance and drug product manufacturing processes, testing of stability samples, method transfers of client methods, and change management.

Key Responsibilities
  • Ensure overall performance of the QC Chemistry team according to KPIs, assuring turn-around-times of all testing and supporting drug substance and drug product manufacturing production.
  • Oversee and manage laboratory exceptions and investigations, and assure timely closure of cGMP KPI deliverables within the group.
  • Motivate the group to perform as efficiently as possible to reduce turn-around-times for testing and approval, ensuring manufacturing is running and tech transfer activity timelines are met.
  • Author procedures, documents, and reports, as needed, to support the QC Chemistry team and tech transfer activities.
  • Prioritize and focus on optimized laboratory systems, including the use of IT systems (e.g., Labware).
  • Identify and implement needed procedural and/or policy changes in areas where needed.
  • Enforce established policies, processes, and procedures, and identify areas where enhancements will improve daily work.
  • Represent the QC Chemistry team 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.
Requirements
  • 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 Chemistry Management experience.
Preferred Requirements
  • Master's degree or Ph.D. in Chemistry, Microbiology, Biological Sciences, Engineering, or related science degree with 6+ years of GMP experience.
  • Previous experience with analytical testing, preferably raw material testing and release in the biopharmaceutical industry.
  • Experience with Microsoft Office, Smartsheet, and laboratory LIMS and ERP systems (e.g., SAP).
Working Conditions & Physical Requirements

The Manager, QC Chemistry will work in a fast-paced laboratory environment, requiring the ability to stand for prolonged periods, sit for prolonged periods, and conduct activities using repetitive motions. The role will also require the ability to operate machinery and/or power tools, move objects up to 33 pounds, bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.

FUJIFILM Diosynth Biotechnologies is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.



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