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.

About the Role

The Supervisor, QC Microbiology is responsible for providing day-to-day supervision, ensuring audit readiness, and planning activities for the laboratory.

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.

• 5-10 approximate # of direct reports 
• Performs other duties, as assigned.

Minimum Requirements

• Bachelors in Life Sciences with 5 years of experience in GMP quality control Microbiology laboratory and/or similar role OR
• Masters in Life Sciences (Biology or Microbiology) with 3 years of experience in GMP quality control Microbiology laboratory and/or similar role
• Experience and working knowledge of LIMS, Smartsheet, Trackwise, 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.
• Prior experience with laboratory equipment, utilities qualification, environmental monitoring qualification, quality systems, automation, IT systems, and/or validation of methodologies.

Preferred Requirements 

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

Working & Physical Conditions

• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.

• Will work in environment operating a motor vehicle or Powered Industrial Truck.

• Ability to discern audible cues

• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

• Ability to stand for prolonged periods of time up to 30 minutes

• Ability to sit for prolonged periods of time up to 30 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 10 pounds.

• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.

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.