FUJIFILM Corporation
Sr. Manufacturing Support Manager
FUJIFILM Corporation, Durham, North Carolina, United States, 27703
Overview:
The work we do at FUJIFILM Diosynth Biotechnologies U.S.A., Inc. has never been more importantand we are looking for talented candidates to join us. Were 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 FDBU and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, youll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. Were proud to cultivate a culture that will fuel your passion, energy, and drivewhat FDBU calls Genki.The
Senior Manufacturing Support Manager
is responsible for buffer/solution prep and weigh/dispense operations within the FDBU Manufacturing organization. This role ensures delivery is aligned to the production execution schedule and adherence to daily and weekly schedule. The individual in this role must be able to identify and communicate improvement opportunities and results to his team, Manufacturing Leadership and Site Leadership. They Initiate and oversees implementation of operational process improvements, new technology or/and modifications to existing technology aimed at enhancing safety and/or quality, cost reduction, efficiency improvements, and minimization of downtime/maximization of asset and resource utilization and quality/safety enhancement. They must be able to identify and communicate improvement opportunities and results. They provide feedback to Manufacturing Leadership regarding intra- and inter-departmental ways of working and potential improvement, alignment and harmonization opportunities.External US:MAJOR ACTIVITIES AND RESPONSIBILITIES:Employee Development/People ManagementPersonnel Management of direct reports (Buffer Prep Production Manager, Weigh and Dispense Production Manager, Buffer Prep Inventory Coordinator) and the employees within those areasWork off shift hours as necessary or assigned/needed. This position supports staff working 7 days per week and up to 16 hours per day. Be available to consult via phone, zoom, and in person, when neededCommunicates with staff directly, with use of Tier 1 board, Tier 2 board, and Shift PlanCoaches team in a learning culture with the goal of achieving employee empowerment and ownershipRecognizes and addresses employee performanceProduction Performance OwnershipConduit between manufacturing production operations and support operations, operations leadership, readiness, planning and support functions and manufacturing execution teamsAssist with management to effectively schedule areas and personnel to maintain production needsComplete periodic reviews of documents, as neededAble to effectively communicate across organizational levels with internal and external clients and partnersParticipates in department and site level OpEx projectsInteraction with groups such as Supply Chain, Materials Management, EHS, Maintenance, Metrology, Manufacturing Technology & Support, Quality Control, and Quality Assurance (QA)Assists in performing Equipment and Room Coordinator tasks, as neededHosts manufacturing Tours for clients, audits, corporate visitorsRepresents Buffer/Solution Prep and Weigh/Dispense at planning & scheduling meetingsAssists team with development objectives and ensures alignment with site and department goalsResponsible for ensuring suites and associated documentation and equipment is always inspection readyComplianceManage deviations, CAPAs, and audit response within Trackwise, on a timely basis related to the buffer/solution prep and weigh/dispense areasCoordinates equipment calibrations and maintenance, as necessaryAny other activities, tasks and duties identified as requiredBACKGROUND REQUIREMENTS:Preferred Education, Experience and Skills - Minimum Requirements:BS/BA (science preferred) and 5+ years of experience in a cGMP (pharmaceutical/manufacturing environment OR AA (science preferred) and 7+ years of experience in a cGMP (pharmaceutical/manufacturing) environment OR 10+ years of experience in a cGMP (pharmaceutical/manufacturing) environment in lieu of a degreeMinimum 2 years management experienceGood working knowledge of cGMP requirements, including documentation and regulatory requirementsDue to the various interactions with external and internal groups, interpersonal and organizational skills are essential attributes. Must have the ability to work in a cross-functional team environment.Experience with the Microsoft Office Suite (Word, Powerpoint, Excel) required. Experience with SAP, PAS-X, DCS/Unicorn/Pi, and/or Trackwise preferred.Physical Ability: ability to walk, climb stairs, crawl, kneel and lift, frequently throughout the shift, up to 12-hours.FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 130 and Export Administration Regulations in 15 C.F.R. Part 730 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Companys ability to secure an export authorization.FDBU 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 e-mail FDBUHR@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.
The work we do at FUJIFILM Diosynth Biotechnologies U.S.A., Inc. has never been more importantand we are looking for talented candidates to join us. Were 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 FDBU and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, youll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. Were proud to cultivate a culture that will fuel your passion, energy, and drivewhat FDBU calls Genki.The
Senior Manufacturing Support Manager
is responsible for buffer/solution prep and weigh/dispense operations within the FDBU Manufacturing organization. This role ensures delivery is aligned to the production execution schedule and adherence to daily and weekly schedule. The individual in this role must be able to identify and communicate improvement opportunities and results to his team, Manufacturing Leadership and Site Leadership. They Initiate and oversees implementation of operational process improvements, new technology or/and modifications to existing technology aimed at enhancing safety and/or quality, cost reduction, efficiency improvements, and minimization of downtime/maximization of asset and resource utilization and quality/safety enhancement. They must be able to identify and communicate improvement opportunities and results. They provide feedback to Manufacturing Leadership regarding intra- and inter-departmental ways of working and potential improvement, alignment and harmonization opportunities.External US:MAJOR ACTIVITIES AND RESPONSIBILITIES:Employee Development/People ManagementPersonnel Management of direct reports (Buffer Prep Production Manager, Weigh and Dispense Production Manager, Buffer Prep Inventory Coordinator) and the employees within those areasWork off shift hours as necessary or assigned/needed. This position supports staff working 7 days per week and up to 16 hours per day. Be available to consult via phone, zoom, and in person, when neededCommunicates with staff directly, with use of Tier 1 board, Tier 2 board, and Shift PlanCoaches team in a learning culture with the goal of achieving employee empowerment and ownershipRecognizes and addresses employee performanceProduction Performance OwnershipConduit between manufacturing production operations and support operations, operations leadership, readiness, planning and support functions and manufacturing execution teamsAssist with management to effectively schedule areas and personnel to maintain production needsComplete periodic reviews of documents, as neededAble to effectively communicate across organizational levels with internal and external clients and partnersParticipates in department and site level OpEx projectsInteraction with groups such as Supply Chain, Materials Management, EHS, Maintenance, Metrology, Manufacturing Technology & Support, Quality Control, and Quality Assurance (QA)Assists in performing Equipment and Room Coordinator tasks, as neededHosts manufacturing Tours for clients, audits, corporate visitorsRepresents Buffer/Solution Prep and Weigh/Dispense at planning & scheduling meetingsAssists team with development objectives and ensures alignment with site and department goalsResponsible for ensuring suites and associated documentation and equipment is always inspection readyComplianceManage deviations, CAPAs, and audit response within Trackwise, on a timely basis related to the buffer/solution prep and weigh/dispense areasCoordinates equipment calibrations and maintenance, as necessaryAny other activities, tasks and duties identified as requiredBACKGROUND REQUIREMENTS:Preferred Education, Experience and Skills - Minimum Requirements:BS/BA (science preferred) and 5+ years of experience in a cGMP (pharmaceutical/manufacturing environment OR AA (science preferred) and 7+ years of experience in a cGMP (pharmaceutical/manufacturing) environment OR 10+ years of experience in a cGMP (pharmaceutical/manufacturing) environment in lieu of a degreeMinimum 2 years management experienceGood working knowledge of cGMP requirements, including documentation and regulatory requirementsDue to the various interactions with external and internal groups, interpersonal and organizational skills are essential attributes. Must have the ability to work in a cross-functional team environment.Experience with the Microsoft Office Suite (Word, Powerpoint, Excel) required. Experience with SAP, PAS-X, DCS/Unicorn/Pi, and/or Trackwise preferred.Physical Ability: ability to walk, climb stairs, crawl, kneel and lift, frequently throughout the shift, up to 12-hours.FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 130 and Export Administration Regulations in 15 C.F.R. Part 730 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Companys ability to secure an export authorization.FDBU 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 e-mail FDBUHR@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.