Manager, QC Lab Support

Position OverviewThe Manager, QC Lab Support is responsible for leading the Lab Support team and the associated activities to ensure compliant and reliable testing for drug substance and drug product. This role applies broad knowledge and expertise in the areas of biopharmaceutical Quality Control for QC Chemistry, QC Bioassay, QC Microbiology, etc. and operational excellence. This Manager, QC Lab Support provides tactical and strategic direction to the QC Lab Support team and promotes the behaviors and principles that drive continuous improvement throughout the

OverviewFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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 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

DescriptionWhat You'll Do

• Leads all areas of QC Lab Support (e.g., change controls, investigations, corrective action preventive action (CAPAs), data review, etc.)
• Develops QC Lab Support goals and strategy in alignment with the production schedule
• Drives Quality Control key performance indicators (KPIs) to support quality, continuous improvement, while escalating and mitigating issues
• Oversees training and development for all QC Lab Support staff
• Ownership and oversite of QC systems and business processes
• Interacts professionally with clients and partners to effectively communicate QC deliverables and commitments
• Leads discussions and responses during inspections, including area readiness prior to these inspections
• Drives and supports alignment and coordination between other FDB sites on QC topics
• Manages and develops direct reports from the Lab Support team
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
• Coaches and guides direct reports to foster professional development
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
• Performs other duties, as assignedMinimum Requirements :
• Bachelor's degree in Chemistry, Microbiology, Biological Sciences, Engineering or related science with 7+ years of experience OR
• Masters degree in Chemistry, Microbiology, Biological Sciences, Engineering or related science with 5+ years of experience OR
• Ph.D. in Chemistry, Microbiology, Biological Sciences, Engineering or related science with 3+ years of experience
• 2-5 years of people management experience
• Experience working in a regulated GMP environment
• Experience managing and developing direct reports and teams
• Extensive experience with Analytical and / or Microbiology methodsPreferred Requirements :
• 5+ years of experience in a GMP environment
• Experience working in a contract manufacturing or testing organization
• Experience with statistical experimental design and data analysis with JMP softwarePhysical and Work Environment Requirements : Ability to discern audible cues.Ability to stand for prolonged periods up to 240 minutes. Ability to sit for prolonged periods up to 240 minutes. Ability to conduct activities using repetitive motions that include wrists, hands and / or fingers.Ability to conduct work that includes moving objects up to 10Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions pounds.Will work in small and / or enclosed spaces.EEO InformationFujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.ADA InformationIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ().