Supervisor, QC Microbiology

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

Job Description

What You'll Do

• 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
  
  

Minimum 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
  
  

Preferred Requirements

• 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
  
  

Physical And Work Environment Requirements

Will work in environment which may necessitate respiratory protection X No Yes

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes

Will work in environment operating a motor vehicle or Powered Industrial Truck. No Yes X

Ability to discern audible cues. No X Yes

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes

Ability to stand for prolonged periods of time. No X Yes Daily for up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)

Ability to sit for prolonged periods of time. No X Yes Daily for up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes

Ability to operate machinery and/or power tools. X No Yes

Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes Will work in warm/cold environments X No Yes Range (If yes, specify approximate temperature ranges.)

Will work in outdoor elements such as precipitation and wind. X No Yes

Will work in small and/or enclosed spaces. X No Yes Will work in heights greater than 4 feet. X No Yes

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.

EEO Information

Fujifilm 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 Information

If 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 (FDBN_PNC@fujifilm.com).