We are seeking a highly motivated individual to join us as a QC Microbiology Supervisor located in Research Triangle Park, NC. Primary responsibilities will be supervision and coordination of staff performing microbiological testing in support of processes and products manufactured at the RTP site. This individual will provide technical leadership to staff to support routine testing including Environmental Monitoring, bioburden and endotoxin testing. They will be the primary contact for the Quality Control laboratory, collaborating with staff outside of the department, facilitating timely and right first-time (RFT) data management and reporting, and assuring testing is completed in support of manufacturing timelines.

The successful candidate will be comfortable working in a fast-paced environment and is flexible, dependable, and able to work independently on assigned tasks.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Individuals in this role are expected to have or build proficiency in the following:

• Provides day to day tactical and logistical support for coordinating execution of activities and/or projects according to timelines.
• Supervises the testing of process intermediates, final products, and stability samples.
• Review and approve data, procedures, and testing in support of batch release.
• Anticipates and responds to technical problems, coordinates investigations and develops appropriate solutions, assuring compliance is maintained and timelines are achieved.
• Evaluates and approves deviations/investigations reports.
• Assists in the hiring process for department staff.
• Communicates department and personnel expectations.
• Conducts performance evaluations and provides constructive feedback to direct reports on an ongoing basis.
• Facilitates development and opportunities to direct reports.
• Assures staff if fully trained and immediately corrects gaps or deficiencies.
• Assures department safety and housekeeping activities are sustained.
• Identifies and implements process improvements.
• Assures overall laboratory is fit for purpose, compliant, and able to support manufacturing activities.
• Coordinates workflow by scheduling and assigning laboratory testing and tasks.

BACKGROUND REQUIREMENTS:

Required education and experience:

• BS/BA in science, preferably in biology, microbiology or related life science field and 7+ years related laboratory experience.
• Prior supervisory experience.
• Quality control experience in the pharmaceutical industry supporting cGMP areas.
• Experience providing technical oversight for OOS investigations in a QC environment.

Desired Qualifications and Skills:

• Demonstrated subject matter expert in microbiological disciplines, including, but not limited to, Bioburden, Endotoxin, Microbial Identification, Culture Purity, Growth Promotion, and Biological Indicator testing.
• Must possess strong organizational skills and a demonstrated ability to be self-directed while managing multiple projects.
• Demonstrated leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization.
• Excellent collaboration skills with colleagues both within and outside of the department.
• Effective communication skills that facilitate project or workflow efficiency and/or distribution of information.
• Capable of coordinating activities and tasks in a high through-put and high quality, RFT environment.
• Effective listening and coaching skills.
• Strong attention to detail.
• Expertise with Labware LIMS and/or Softmax Pro is a plus.
• Prior experience within Contract Testing Laboratory or CDMO space is highly desirable.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

FDBU 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 e-mail FDBUHR@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.