Analyst, QC Bioassay - Fujifilm

Position Overview

The QC Bioassay Analyst works with direction from manager 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 Analyst 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 Analyst is primarily responsible for executing routine analytical methods in support of manufacturing, and as needed supporting laboratory execution of analytical method transfers and validations. The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

Job Description

Major Accountabilities:

• 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.
• Supports laboratory execution of analytical method transfers and validations
• Assists with authoring and reviewing QC SOPs.
• 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:

• Bachelor’s degree in life sciences,Virology, Biology, Chemistry, Biochemistry or related science field with 0 - 2 years of experience
• 0-2 years GMP laboratory experience

Preferred Requirements:

• Experience with LIMS software

Working Environment:

• Ability to stand for prolonged periods of time up to 240 minutes.
• Ability to sit for prolonged periods of time up to 240 minutes.
• Ability to conduct work that includes moving objects up to 10 pounds.

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.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).