FUJIFILM Corporation
Manager, QC Chemistry
FUJIFILM Corporation, Holly Springs, North Carolina, United States, 27540
Overview:
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more importantand 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 peoples 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 usWe 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 solutionsto 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 RoleThe 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 DoEnsures GMP compliant laboratory operations according to guidelinesManages 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 managementEnsures 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 groupMotivates 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 metAuthors procedures, documents and reports, as needed, to support the QC Chemistry team and tech transfer activitiesPrioritizes 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 neededEnforces established policies, processes and procedures and identifies areas where enhancements will improve daily workRepresents 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 objectivesAuthors, reviews, and approves data reports, out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls, as neededEnsures the team and laboratory maintain inspection readiness for customer visits, audits and regulatory inspections following cGMP guidelines and FUJIFILM Diosynth Biotechnologies processesRepresents the QC Chemistry team during internal, customer and regulatory auditsEnsures the timely delivery of results within deadlines by effectively managing the performance of the QC Chemistry teamExecutes managerial tasks per the FUJIFILM Diosynth Biotechnologies policies including coaching, guidance, and development of team membersManages 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 managementSupports 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 assignedMinimum Requirements:Bachelors degree with 8+ years of experience in a GMP environmentORMasters Degree with 6+ years of experience in GMP environmentORPh.D. with 4+ years of experience in GMP environment5+ years of experience with analytical testing, preferably rawmaterial testing and releasePrevious QC Chemistry Management experiencePreferred Requirements:
Masters degree or Ph.D. in Chemistry, Microbiology, BiologicalSciences, Engineering or related science degree with 6+ years of GMPexperience ORPh.D. in Chemistry, Microbiology, Biological Sciences with 4+ years ofGMP experiencePrevious experience with analytical testing, preferably raw materialtesting and release in the biopharmaceutical industryExperience with Microsoft Office, Smartsheet and laboratory LIMSand ERP systems (e.g., SAP)WORKING CONDITIONS & PHYSICAL REQUIREMENTSAbility to stand for prolonged periods of time up to 120 minutesAbility to sit for prolonged periods of time up to 240 minutesAbility to conduct activities using repetitive motions that include writs, hands and/or fingers.Ability to operate machinery and/or power toolsAbility to conduct work that includes moving objects up to 33 poundsAbility to bend, push or pull, reach to retrieve materials from 18 to 60 in height and use twisting motions.Ability to work in environments between -20 and -70 C for a few minutes with appropriate PPEWill work in heights greater than 4 feetFDBN 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 identify or any other protected class. If an accommodation to the application process is needed, please email
FDBN_PNC@fujifilm.com .To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more importantand 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 peoples 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 usWe 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 solutionsto 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 RoleThe 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 DoEnsures GMP compliant laboratory operations according to guidelinesManages 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 managementEnsures 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 groupMotivates 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 metAuthors procedures, documents and reports, as needed, to support the QC Chemistry team and tech transfer activitiesPrioritizes 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 neededEnforces established policies, processes and procedures and identifies areas where enhancements will improve daily workRepresents 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 objectivesAuthors, reviews, and approves data reports, out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls, as neededEnsures the team and laboratory maintain inspection readiness for customer visits, audits and regulatory inspections following cGMP guidelines and FUJIFILM Diosynth Biotechnologies processesRepresents the QC Chemistry team during internal, customer and regulatory auditsEnsures the timely delivery of results within deadlines by effectively managing the performance of the QC Chemistry teamExecutes managerial tasks per the FUJIFILM Diosynth Biotechnologies policies including coaching, guidance, and development of team membersManages 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 managementSupports 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 assignedMinimum Requirements:Bachelors degree with 8+ years of experience in a GMP environmentORMasters Degree with 6+ years of experience in GMP environmentORPh.D. with 4+ years of experience in GMP environment5+ years of experience with analytical testing, preferably rawmaterial testing and releasePrevious QC Chemistry Management experiencePreferred Requirements:
Masters degree or Ph.D. in Chemistry, Microbiology, BiologicalSciences, Engineering or related science degree with 6+ years of GMPexperience ORPh.D. in Chemistry, Microbiology, Biological Sciences with 4+ years ofGMP experiencePrevious experience with analytical testing, preferably raw materialtesting and release in the biopharmaceutical industryExperience with Microsoft Office, Smartsheet and laboratory LIMSand ERP systems (e.g., SAP)WORKING CONDITIONS & PHYSICAL REQUIREMENTSAbility to stand for prolonged periods of time up to 120 minutesAbility to sit for prolonged periods of time up to 240 minutesAbility to conduct activities using repetitive motions that include writs, hands and/or fingers.Ability to operate machinery and/or power toolsAbility to conduct work that includes moving objects up to 33 poundsAbility to bend, push or pull, reach to retrieve materials from 18 to 60 in height and use twisting motions.Ability to work in environments between -20 and -70 C for a few minutes with appropriate PPEWill work in heights greater than 4 feetFDBN 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 identify or any other protected class. If an accommodation to the application process is needed, please email
FDBN_PNC@fujifilm.com .To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.