Scientist 2, QC Analytical Development Chemistry

Fujifilm•Holly Springs, NC

About The Position

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. Company Overview 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

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

Nice To Haves

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

Responsibilities

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