The Scientist 2, QC Analytical Development Chemistry is responsible for coordinating the transfer of analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Holly Springs. The Scientist 2, QC Analytical Development Chemistry ensures GMP compliant laboratory operations in accordance with regulatory  guidelines. This role coordinates analytical method transfers from clients, including the following analytical methods: chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc.

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

What You'll Do

• Leads analytical chemistry method tech transfer and execution including method verification, transfer and validation
• Interfaces with customers and program management to identify analytical needs and performs risk and gap assessments during project scoping
• Participates in regular meetings for TT programs with cross-functional teams and key stakeholders
• Serves as the subject matter expert (SME) to author and review SOPs, transfer plans, protocols, and reports
• 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
• Supports the QC AD team to investigate any project challenges with necessary risk assessment tools and techniques
• Supports best practices for TT and PPQ strategies globally, as required
• Performs other duties, as assigned

Minimum Requirements:

• B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or
related science field with 8+ years of analytical laboratory experience
preferably in biotechnology, Pharma, Contract Research Organization
(CRO), or Contract Laboratory Organization (CLO) OR
• M.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or
related science field with 6+ years of experience, OR
• Ph.D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or
related science field with 4+ years of experience
• 4+ 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:

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 wrists, hands and/or fingers.

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

Will work in warm/cold environments (5 C)

Will work in small and/or enclosed spaces.

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.

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.

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).