We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
We are seeking a highly motivated individual to join us as a QC Microbiology Supervisor in our Contract Manufacturing site located in Research Triangle Park, NC. The RTP facility is a 7 day a week, 2-shift operation. This position will primarily be a Monday – Friday 1st shift position, but may require occasional weekend and/or holiday work. This role will be a hands-on leader reporting to a Quality Control Manager.
Primary responsibilities will be to supervise and coordinate 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 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 has the ability to work independently on assigned tasks.
Essential Functions and Duties:
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 approves: 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 met
- Evaluates and approves deviations/investigations reports
- Assists in the hiring process for department staffing
- 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 staff
- 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 workloads
Required education and experience:
- BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field and 5+ years related laboratory 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 several microbiological disciplines
- 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
- Must have excellent collaboration skills with colleagues both within and outside of the department
- Must possess effective communicate skills that effectively facilitate project or workflow efficiency and/or distribute 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.
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.
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.