Scientist 2, QC Analytical Development - Chemistry

Fujifilm • Holly Springs, NC

4d • Onsite

About The Position

Position Overview The Scientist 2, QC Analytical Development (AD) 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 QC AD Chemistry Scientist 2 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 Job Description What You'll Do In-depth technical knowledge of Analytical Chemistry and ability to analyze raw data, assess assay and system suitability criteria. Relevant experience in analytical method development and validation. Demonstrated application and knowledge of ICH guidelines on analytical method validation. Experience with customers and analytical method transfers. Experience with project management and demonstrated ability to monitor project progress and provide status updates. Demonstrated communication skills, technical proficiency, scientific creativity, collaboration with others and independent thought. Planning of projects in terms of timing, execution of deliverables and resource allocation. Excellent interpersonal skills including the ability to work as part of a cross-functional team, collaborate with external clients, adapt to changing business needs, communicate with confidence, challenge others when necessary and display strong problem-solving capabilities. Excellent English oral and written communication skills as well as demonstrated expertise with Microsoft Excel, Project, Word and SmartSheet. Familiarity with LIMS Software. Proficient in physical and chemical testing methods for biological products, including 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 sub-visible particle analysis, and glycan analysis, and peptide mapping. Displays an advanced knowledge of GMP requirements for laboratory operations. Possesses a broad knowledge of quality control operations, systems, and directives.

Requirements

• In-depth technical knowledge of Analytical Chemistry and ability to analyze raw data, assess assay and system suitability criteria.
• Relevant experience in analytical method development and validation.
• Demonstrated application and knowledge of ICH guidelines on analytical method validation.
• Experience with customers and analytical method transfers.
• Experience with project management and demonstrated ability to monitor project progress and provide status updates.
• Demonstrated communication skills, technical proficiency, scientific creativity, collaboration with others and independent thought.
• Planning of projects in terms of timing, execution of deliverables and resource allocation.
• Excellent interpersonal skills including the ability to work as part of a cross-functional team, collaborate with external clients, adapt to changing business needs, communicate with confidence, challenge others when necessary and display strong problem-solving capabilities.
• Excellent English oral and written communication skills as well as demonstrated expertise with Microsoft Excel, Project, Word and SmartSheet.
• Familiarity with LIMS Software.
• Proficient in physical and chemical testing methods for biological products, including 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 sub-visible particle analysis, and glycan analysis, and peptide mapping.
• Displays an advanced knowledge of GMP requirements for laboratory operations.
• Possesses a broad knowledge of quality control operations, systems, and directives.
• Bachelor's Degree in 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 of experience in a GMP environment

Nice To Haves

• Master's Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 7+ years of experience; OR, Ph.D. in 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.
• Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system).

Responsibilities

• coordinating the transfer of analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories
• ensures GMP compliant laboratory operations in accordance with regulatory guidelines
• coordinates analytical method transfers from clients

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees