Analytical Development Bioassay Scientist 2

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 Analytical Development (AD) Bioassay Scientist 2 is responsible for coordinating the transfer of cell-based and plate-based analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). The QC AD Bioassay Scientist 2 ensures GMP compliant laboratory operations in accordance with regulatory guidelines. This role acts as a QC Bioassay subject matter expert (SME) during interactions with customers and cross-functional teams to scope bioassay analytical testing plans and achieve project milestones. This role authors/reviews transfer plans, method transfer documents, and transfer summary reports to support tech transfers for QC Analytical Development.

What You'll Do

• Leads analytical method transfer and validation activities for cell- and plate-based Bioassays for the QC Analytical Development team• Supports change controls, out-of-specification (OOS) and out-of-trend (OOT) investigations, and CAPAs for the QC Bioassay team, as needed• Interfaces with customers and program management to identify bioassay analytical needs and perform risk and gap assessments during project scoping• Participates in regular meetings for TT programs with cross-functional teams and key stakeholders• Serves as the QC Analytical Development Bioassay subject matter expert (SME) to author and review SOPs, transfer plans, protocols, and reports as part of the tech transfer process to onboard client programs• Liaises with Contract Laboratory Organizations (CLOs), QC testing teams, Quality Assurance (QA), and Process Science groups to ensure prioritization of non-compendial and compendial method transfer activities according to deadlines• Collaborates with the LIMS team and IT department to build new analytical method functionality that meets end-user and customer requirements.• Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.)• Supports regulatory requests and inspections• Performs other duties, as assigned

Minimum Requirements:

• B.S. in Microbiology, Virology, Biology, Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 9+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO)• 4-6 years experience in a GMP environment

Preferred Requirements:

• M.S. in Virology, Microbiology, Biology, Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 7+ years of experience, OR• Ph.D. in Virology, Microbiology, Biology, Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of experience• Experience with Customer Relationship Management• Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting

Physical and Work Environment Requirements:

Will work in environment which may necessitate respiratory protection

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Ability to stand for prolonged periods of time up to 120 minutes

Ability to sit for prolonged periods of time up to 120 minutes

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

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

Will work in warm/cold environments

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.