Supervisor, QC Microbiology

Fujifilm•Holly Springs, NC

About The Position

The Supervisor, QC Microbiology, is responsible for providing day-to-day supervision, ensuring audit readiness, and planning activities for the laboratory. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

Bachelors in Life Sciences (Biology or Microbiology) with 4+ years of relevant experience OR
Masters in Life Sciences (Biology or Microbiology) with 2+ years of relevant experience
2-3 years of people management experience
Experience working in a regulated GMP environment
Experience and working knowledge of LIMS, Smartsheet, Track wise, Master Control, and/or Kneat validation software
Experience with management of complex projects
Experience and understanding of compendial microbial methods, Data Integrity, and application of regulatory requirements for QC Microbiology
Experience with laboratory equipment, utilities qualification, environmental monitoring qualification, quality systems, automation, IT systems, and/or validation of methodologies

Nice To Haves

Experience leading teams in a laboratory setting
Experience and advanced understanding of large-scale biomanufacturing processes
Experience in leading startup activities and program-forming initiatives, e.g., creation of systems or business processes that support Quality objectives
Experience and familiarity with Technology Transfer and/or Product Commercialization processes

Responsibilities

Provides day-to-day supervision and scheduling of the QC Microbiology laboratory team
Applies expertise in laboratory methodology and compendial requirements for QC Microbiology testing and acts as primary point of contact for their team and first-line escalation point in areas of their responsibility
Leads team to meet project deliverables
Demonstrates ability to set up and maintain operations of a QC Microbiology laboratory
Assists senior management with resource planning and budget-related tasks
Ensures efficient team scheduling, management of sample collection and testing to meet deliverables on time
Gathers recommendations for enhancements and gaps related to their areas of responsibility and, in collaboration with leadership, prioritizes and implements solutions accordingly
Maintains relationships with site-based customers and global colleagues and provides updates to leadership as requested
Ensures allocation and planning of adequate resources for laboratory testing activities, QA support activities, and provides technical guidance to the team
Leads cross-functional teams to achieve operational readiness objectives and new product introduction goals using a risk-based, right-size approach
Leads or guides laboratory staff in the investigation of lab deviations, excursions, and implementation of CAPAs as needed
Serves as Subject Matter Expert (SME) in audits and inspections for the laboratory. Prepares and guides laboratory team to ensure audit readiness
Establishes and maintains internal and external training goals for self and team to ensure compliance with cGMPs and regulatory requirements
Provides training, coaching, and mentorship to their team and peers as applicable. Works with their team to identify areas of improvement, reduce blind spots, and give opportunities for increasing responsibility as appropriate for each individual's career objectives
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 assigned