FUJIFILM Corporation
QC Manager, Virology
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 & CDMO
The 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 us
We 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 solutions to 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 This Role
The Manager, QC Virology oversees the QC Virology team, ensuring GMP-compliant laboratory operations in accordance with regulatory guidelines. This role involves direct management of PCR, RT-PCR, qPCR assays, Adventitious Virus (AVA) testing, and Mouse Minute Virus (MMV) testing. As a technical subject matter expert, the Manager provides support for troubleshooting complex investigations and optimizing laboratory systems while ensuring accurate documentation and compliance with GMP standards. Additionally, this role represents the QC Virology team during customer and regulatory audits and foster the development of team members through effective leadership.
What You’ll Do
• Manages and prioritizes the daily activities of QC Virology together with planners in the team, assuring a dedicated focus on release, stability and clinical testing.
• Ensures overall performance of QC Virology according to KPIs, delivering results within expected turnaround times for all release, stability, and clinical testing performed in the QC Virology department.
• Assures timely analysis, review, and approval of results in support of on-time CoA issuance or stability time points, including approving data reports within the team and area of discipline/focus.
• Oversees and manages laboratory exceptions and investigations, ensuring timely closure within the group according to Quality metrics.
• Ensures GMP-compliant laboratory operations according to GMP guidelines and prepares the department for customer visits, audits, and
regulatory inspections.
• Leads projects such as method transfers and qualifications in support of new product introductions for new and existing customers, focusing on optimized laboratory systems and IT tools (e.g., Labware).
• Motivates the group to perform efficiently to reduce turnaround times for the release of commercial, stability, and clinical products while managing and prioritizing the preparation of procedures, protocols, and associated reports.
• Leads a team responsible for executing analytical methods that require aseptic techniques, including viral infectivity assays, qPCR assays, cell-based assays, and clean cell culture.
• Manages lab activities and directs the team as needed while leading method verification, qualification, validation activities, and maintaining lab equipment.
• Authors, reviews, and approves SOPs, protocols, reports, change management reports, Trackwise deviations, and investigations for the QC Virology team as needed.
• Performs investigations and manages complex issues to support team success while proactively identifying technical gaps and areas for
improvement related to quality.
• Represents QC Virology on cross-functional Tech Transfer teams to implement, transfer, and validate client methods ahead of new program campaigns.
• Assists in setting and reporting measurable goals and targets along with mitigation plans as appropriate while managing complex problem-solving that may impact compliance or personnel issues.
• Provides leadership and mentoring to aid in team development through effective project management and technical problem-solving.
• Performs other duties as assigned.
Basic Requirements
• Bachelor’s degree with 8+ years of experience in a GMP environment
OR
• Master’s degree 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
• 2- 3 years QC Virology leadership experience
• Prior experience and knowledge in Virology testing
• Prior experience working with BSL1 and BSL2 viruses in a GMP lab environment including mammalian cell culture propagation and
maintenance
• Prior experience and advanced knowledge of cGMPs, ICH, USP, EP, JP and FDA requirements as it relates to Virology analytical methods.
• Prior experience and advanced knowledge of QC testing involving qPCR assays, Adventitious Virus testing, and Mouse Minute Virus testing.
Preferred Requirements
• Prior experience and knowledge growing, purifying, and quantitating live viral stocks for use in infectivity assays.
Working Conditions & Physical Requirements
Ability to stand for prolonged periods of time.
Ability to sit for prolonged periods of time.
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
Ability to conduct work that includes moving objects up to 33 pounds
Ability 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 PPE
Will work in heights greater than 4 feet
FDBN 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.
Job Locations US-NC-Holly Springs
Posted Date 7 hours ago (10/30/2024 4:10 PM)
Requisition ID 2024-32445
Category Quality Control
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The 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 us
We 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 solutions to 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 This Role
The Manager, QC Virology oversees the QC Virology team, ensuring GMP-compliant laboratory operations in accordance with regulatory guidelines. This role involves direct management of PCR, RT-PCR, qPCR assays, Adventitious Virus (AVA) testing, and Mouse Minute Virus (MMV) testing. As a technical subject matter expert, the Manager provides support for troubleshooting complex investigations and optimizing laboratory systems while ensuring accurate documentation and compliance with GMP standards. Additionally, this role represents the QC Virology team during customer and regulatory audits and foster the development of team members through effective leadership.
What You’ll Do
• Manages and prioritizes the daily activities of QC Virology together with planners in the team, assuring a dedicated focus on release, stability and clinical testing.
• Ensures overall performance of QC Virology according to KPIs, delivering results within expected turnaround times for all release, stability, and clinical testing performed in the QC Virology department.
• Assures timely analysis, review, and approval of results in support of on-time CoA issuance or stability time points, including approving data reports within the team and area of discipline/focus.
• Oversees and manages laboratory exceptions and investigations, ensuring timely closure within the group according to Quality metrics.
• Ensures GMP-compliant laboratory operations according to GMP guidelines and prepares the department for customer visits, audits, and
regulatory inspections.
• Leads projects such as method transfers and qualifications in support of new product introductions for new and existing customers, focusing on optimized laboratory systems and IT tools (e.g., Labware).
• Motivates the group to perform efficiently to reduce turnaround times for the release of commercial, stability, and clinical products while managing and prioritizing the preparation of procedures, protocols, and associated reports.
• Leads a team responsible for executing analytical methods that require aseptic techniques, including viral infectivity assays, qPCR assays, cell-based assays, and clean cell culture.
• Manages lab activities and directs the team as needed while leading method verification, qualification, validation activities, and maintaining lab equipment.
• Authors, reviews, and approves SOPs, protocols, reports, change management reports, Trackwise deviations, and investigations for the QC Virology team as needed.
• Performs investigations and manages complex issues to support team success while proactively identifying technical gaps and areas for
improvement related to quality.
• Represents QC Virology on cross-functional Tech Transfer teams to implement, transfer, and validate client methods ahead of new program campaigns.
• Assists in setting and reporting measurable goals and targets along with mitigation plans as appropriate while managing complex problem-solving that may impact compliance or personnel issues.
• Provides leadership and mentoring to aid in team development through effective project management and technical problem-solving.
• Performs other duties as assigned.
Basic Requirements
• Bachelor’s degree with 8+ years of experience in a GMP environment
OR
• Master’s degree 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
• 2- 3 years QC Virology leadership experience
• Prior experience and knowledge in Virology testing
• Prior experience working with BSL1 and BSL2 viruses in a GMP lab environment including mammalian cell culture propagation and
maintenance
• Prior experience and advanced knowledge of cGMPs, ICH, USP, EP, JP and FDA requirements as it relates to Virology analytical methods.
• Prior experience and advanced knowledge of QC testing involving qPCR assays, Adventitious Virus testing, and Mouse Minute Virus testing.
Preferred Requirements
• Prior experience and knowledge growing, purifying, and quantitating live viral stocks for use in infectivity assays.
Working Conditions & Physical Requirements
Ability to stand for prolonged periods of time.
Ability to sit for prolonged periods of time.
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
Ability to conduct work that includes moving objects up to 33 pounds
Ability 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 PPE
Will work in heights greater than 4 feet
FDBN 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.
Job Locations US-NC-Holly Springs
Posted Date 7 hours ago (10/30/2024 4:10 PM)
Requisition ID 2024-32445
Category Quality Control
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies