Senior Analyst 1, QC Analytical Development - Chemistry

HireLifeScience; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies Holly Springs seeks a Senior Analyst 1, QC AD Chemistry to support analytical method transfers and validations for drug substance and drug product into QC laboratories. The role emphasizes GMP compliance and collaborative execution with cross-functional teams.

The candidate will author and review SOPs, protocols, and technical reports, while coordinating with CLOs, QA, and Process Science to ensure timely method transfers and regulatory readiness.

Qualifications

• Knowledge of cGMPs, ICH, FDA, USP, EP requirements related to analytical methods.
• Experience with analytical methods in biopharma including chromatography, spectroscopy, and electrophoresis.
• Ability to write deviations, CAPA, and scientific reports.
• Proficient with MS Office products and data analysis tools.

Responsibilities

• Executes verification, transfer, and validation of analytical methods (GC, HPLC, UPLC, SEC; MS, LC-MS/MS; UV/Vis; FTIR).
• Authors and reviews SOPs, protocols, and technical reports.
• Supports cross-functional teams (CLOs, QA, Process Science) to ensure method transfer according to deadlines.
• Collaborates with LIMS and IT to build new method functionalities.
• Ensures regulatory readiness and compliance (ICH, FDA) for TT programs.
• Trains QC Chemistry lab associates and supports investigations.

Skills

GMP knowledge

Analytical method transfer

Cross-functional collaboration

Strong written communication

MS Office

Education

Bachelor's degree in Chemistry, Biology, or related field

Master's degree in Biology, Chemistry, Biochemistry, or related field

Tools

LIMS software

Job description

Position Overview

Senior Analyst 1, QC Analytical Development (AD) Chemistry works with limited direction to support the execution of analytical method transfers and validations for drug substance (DS) and drug product (DP) manufacturing into the Quality Control laboratories of FUJIFILM Biotechnologies Holly Springs. The analytical chemistry methods used in biological product manufacturing include chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Senior Analyst 1, QC AD Chemistry adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and authors and reviews procedures, SOPs, and technical reports.

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

• Executes verification, transfer, and validation of analytical chemistry methods 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, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. with cellular and molecular analytical testing methods.
• Ensures compliance of analytical testing with appropriate GMP regulations.
• Participates in regular meetings for TT programs with cross-functional teams and key stakeholders.
• Authors and reviews SOPs, protocols, and technical reports.
• Works cross-functionally with Contract Laboratory Organizations (CLOs), QC testing teams, Quality Assurance (QA), and Process Science groups to ensure transfer of non-compendial and compendial methods 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, as needed.
• Supports best practices for TT and PPQ strategies globally, as required.
• Coordinates and supports QC AD Chemistry lab activities, as needed.
• Provides training for QC Chemistry lab associates.
• Utilizes MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
• Performs other duties, as assigned.

Knowledge, Skills, and Abilities

• Knowledge of cGMPs, ICH, USP, EP, JP and FDA requirements as it relates to physical and chemical analytical methods.
• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, and Power Point).
• Ability to work with minimal supervision.
• Ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
• Excellent verbal and written communication skills and attention to detail.
• Thorough understanding of pharmaceutical/biotech testing.
• Proven ability to conduct investigations, writing deviations and CAPA's.
• Superior technical writing and problem-solving skills required.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• A./B.S. degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline with 2+ years of experience; OR,
• Masters degree in biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 0 years' experience.
• 3+ years laboratory experience.
• 1-3 years GMP laboratory experience.
• Experience in a GMP environment.
• Experience with physical and chemical analytical testing methods used in biological product manufacturing 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, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. with cellular and molecular analytical testing methods.

Preferred Qualifications

• Masters degree in Biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 1+ years' experience.
• Experience with LIMS software.

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:

• 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 for up to 240 minutes.
• Ability to sit for prolonged periods of time for up to 240 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.
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.
• Will work in warm/cold environments (5C Range).
• Will work in small and/or enclosed spaces.

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 ([e-mail]).