FUJIFILM Holdings America Corporation
Supervisor - DSM (Upstream)
FUJIFILM Holdings America 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 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 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 USAbout This RoleThis role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.What You'll DoProject Phase (Through Mid-2025)Supports Factory Acceptance Testing (FAT) at the vendor site as requiredSupports Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicablePerforms other operational readiness tasks as required, such as: document review/approval, team onboarding, and materials managementSupervises manufacturing associates on technical and operational topics, such as: area unit operations and equipmentAdministers company policies, such as, but not limited to: travel & expense, time reporting, and time off that directly impact employeesOperations Phase (Starting Mid-2025)Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associatesCoordinates the execution of the manufacturing schedule through daily shift assignments, lead daily huddles, and manages escalationsFosters an inclusive, people-first culture with regular communication, conducting 1:1s on a defined cadence with direct reportsMaintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date trainingSupports manufacturing investigations and continuous improvement projectsCoordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment, such as but not limited to: maintenance, calibration activities and the use of manufacturing equipmentAdministers company policies, such as but not limited to: time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employeesPerforms other job as assignedWho You AreYou have a high degree of knowledge and expertise of the operation of production equipment in their respective functional area. You have an understanding of manufacturing run cadence and order of shift activities. You have expertise in cGMP, safety and FDBN operational procedures. You have a strong cross functional partnership with Quality, Process Sciences, Process Engineering and others. You are able to create and maintain a collaborative and inclusive team. You have the ability to travel and have a valid passport.Basic RequirementsHigh School Diploma or GED with 8 years of experience from a similar role in large pharma/biotech operations or projectsPreferred RequirementsBA/BS Degree in Life Sciences with 4+ years of experience from a similar role in large pharma/biotech operations or projects
ORAssociates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projects
ORMilitary Experience of equivalenceExperience in manufacturing of biological products, familiar with GMP/GLP requirementsPrevious experience leading, supervising or managing othersPHYSICAL REQUIREMENTSPHYSICAL DEMANDSWill work in an environment which may necessitate respiratory protectionMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearting conservation programAbility to discern audible cuesWORKING ENVIRONMENTPHYSICAL DEMANDSAbility to ascend or descend ladders, scaffolding, ramps, etc.Ability to stand for prolonged periods of timeAbility to sit for prolonged periods of timeAbility to conduct activities using repetitive motions that include wrist, hands and/or fingers.Ability to conduct work that includes moving objects up to 33 lbs.ENVIRONMENTAL CONDITIONSWill 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 emailFDBN_PNC@
.
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 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 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 USAbout This RoleThis role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.What You'll DoProject Phase (Through Mid-2025)Supports Factory Acceptance Testing (FAT) at the vendor site as requiredSupports Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicablePerforms other operational readiness tasks as required, such as: document review/approval, team onboarding, and materials managementSupervises manufacturing associates on technical and operational topics, such as: area unit operations and equipmentAdministers company policies, such as, but not limited to: travel & expense, time reporting, and time off that directly impact employeesOperations Phase (Starting Mid-2025)Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associatesCoordinates the execution of the manufacturing schedule through daily shift assignments, lead daily huddles, and manages escalationsFosters an inclusive, people-first culture with regular communication, conducting 1:1s on a defined cadence with direct reportsMaintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date trainingSupports manufacturing investigations and continuous improvement projectsCoordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment, such as but not limited to: maintenance, calibration activities and the use of manufacturing equipmentAdministers company policies, such as but not limited to: time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employeesPerforms other job as assignedWho You AreYou have a high degree of knowledge and expertise of the operation of production equipment in their respective functional area. You have an understanding of manufacturing run cadence and order of shift activities. You have expertise in cGMP, safety and FDBN operational procedures. You have a strong cross functional partnership with Quality, Process Sciences, Process Engineering and others. You are able to create and maintain a collaborative and inclusive team. You have the ability to travel and have a valid passport.Basic RequirementsHigh School Diploma or GED with 8 years of experience from a similar role in large pharma/biotech operations or projectsPreferred RequirementsBA/BS Degree in Life Sciences with 4+ years of experience from a similar role in large pharma/biotech operations or projects
ORAssociates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projects
ORMilitary Experience of equivalenceExperience in manufacturing of biological products, familiar with GMP/GLP requirementsPrevious experience leading, supervising or managing othersPHYSICAL REQUIREMENTSPHYSICAL DEMANDSWill work in an environment which may necessitate respiratory protectionMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearting conservation programAbility to discern audible cuesWORKING ENVIRONMENTPHYSICAL DEMANDSAbility to ascend or descend ladders, scaffolding, ramps, etc.Ability to stand for prolonged periods of timeAbility to sit for prolonged periods of timeAbility to conduct activities using repetitive motions that include wrist, hands and/or fingers.Ability to conduct work that includes moving objects up to 33 lbs.ENVIRONMENTAL CONDITIONSWill 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 emailFDBN_PNC@
.
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.