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Chemistry Manager

1 month ago

Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full time

Preferred Requirements:

  • Previous QC Chemistry leadership experience in a GMP environment


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, audits and regulatory inspections following cGMP guidelines and FUJIFILM Diosynth Biotechnologies processes

• Represents the QC Chemistry team during internal, customer and regulatory audits

• Ensures the timely delivery of results within deadlines by effectively managing the performance of the QC Chemistry team

• Executes managerial tasks per the FUJIFILM Diosynth Biotechnologies policies including coaching, guidance, and development of team members

• Manages complex problem solving, providing mitigation/outcome to management/team. Decisions at this level include those that have potential compliance impact to methods, results, product, and/or Quality systems, decisions with impact to customers, or pertaining to personnel issues that must be handled with consultation and recommendations to management

• 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.

• Performs other duties, as assigned

Minimum 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 OR

• Ph.D. in Chemistry, Microbiology, Biological Sciences with 4+ 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)