The Scientist 1, QC Analytical Development (AD) Bioassay coordinates the transfer of cell- 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 Scientist 1, QC AD Bioassay ensures GMP compliant laboratory operations in accordance with regulatory guidelines. This role periodically interfaces with customers and cross-functional teams to scope bioassay analytical testing plans and achieve project milestones. This role authors and reviews transfer plans, method transfer documents, and transfer summary reports to support tech transfers for QC Analytical Development.

What You'll Do

• Manages 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
• Authors 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 5+ years
of experience OR
• M.S. in Virology, Microbiology, Biology, Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years
of experience, OR
• Ph.D. in Virology, Microbiology, Biology, Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 1+ years
of experience
• 3+ years of experience working in a regulated GMP environment

Preferred Requirements:

• Experience with Customer Relationship Management
• Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support
and troubleshooting
• Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA),
document management system)

Physical and Work Environment Requirements:

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 240 minutes.

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

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.