Scientist 2, QC Analytical Development - Chemistry

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:

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.

Minimum Qualifications

• 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

Preferred Qualifications

• 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).

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:

• 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.

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.

*LI-Onsite

EEO Information

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.

ADA Information

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 ([email protected]).