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 Lead Associate II (Technical Review) 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 be a Monday – Friday 1st shift position. This role will be a hands-on resource reporting to a Quality Control Supervisor and must be able to perform laboratory work as assigned to meet production schedules and project milestones.
Primary responsibilities will be to provide technical review for a variety of analytical disciplines such as HPLC (SEC, IEX, UPLC, & RP), Gel-based protein separation, CE-SDS, pH, osmolality, TOC, and appearance testing.
Additional responsibilities may include assisting with laboratory investigations, working within project teams and interacting with internal and external customers.
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:
- Working in a GMP regulated environment, attention to detail, highly organized with excellent documentation skills
- Proficiency in HPLC using Empower
- Can effectively manage time to meet test schedules, adapt to change in priorities, and be flexible to help provide testing coverage for off-shift and weekend activities
Desired Qualifications and Skills:
- Bachelor’s Degree in science, preferably chemistry, biochemistry, pharmaceutical sciences or related technical field.
- Minimum 8+ years of experience in the pharmaceutical/biotech industry with a minimum of 2 years’ experience working in a GMP / FDA-regulated environment.
- Knowledge of Trackwise, LABWARE LIMs and SAP preferred
- Knowledge of Gel and Plate Based Assays Preferred
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.