QC Bioassay Sr. Analyst I

Overview

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.

External US

About the Role

The QC Bioassay Sr.

Analyst 1 works with limited direction to execute QC cell- and plate-based analytical methods including protein binding assays, cell-based potency assays, cell culture routine maintenance, and residual testing for DNA, Host Cell Protein (HCP), Protein A/G.

The QC Bioassay Sr.

Analyst 1 adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identify laboratory exceptions, invalid assays, deviations, change controls and corrective and preventative actions (CAPAs). The QC Bioassay Sr.

Analyst 1 is primarily responsible for executing routine analytical methods in support of manufacturing, supporting laboratory execution of analytical method transfers and validations, and training other QC Bioassay laboratory associates. The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.

What You'll Do

• Executes cell- and plate-based analytical methods including protein binding assays (e.g. ELISA, Dot Blot, etc.), cell-based potency assays, cell culture maintenance, and residual testing for DNA, Host Cell Protein (HCP), Protein A/G• Ensures analytical testing of in process, drug substance (DS), drug product (DP) and stability samples are performed according to appropriate GMP regulations• Ensures analytical testing data is captured in LIMS software and data integrity is maintained• Reports assay performance and assists with implementing improvements that ensure quality and efficiency within QC Bioassay• Identifies and follows-up on excursions and deviations and initiate corrective and preventative actions (CAPAs)• Coordinates and supports QC Bioassay lab activities, as needed• Provides training for QC Bioassay lab associates• Supports laboratory execution of analytical method transfers and validations• Assists with authoring and reviewing SOPs and technical reports• Works cross functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives• Performs other duties, as assigned

Minimum Requirements:

• B.S. in Microbiology, Virology, Biology, Chemistry, Biochemistry, Biological Sciences or related science field with 3+ years of experience• 3+ years laboratory experience• 1-3 years GMP laboratory experience

Preferred Requirements:

• M.S. in Virology, Microbiology, Biology, Chemistry, Biochemistry, Biological Sciences, or related science field with 0+ years of experience• Experience with LIMS software

Physical and Work Environment Requirements:

Ability to sit for prolonged periods of time up to 240 minutes.

Ability to stand for prolonged periods of time up to 240 minutes.

Ability to conduct work that includes moving objects up to 10 pounds.

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.