Senior Analyst 1, QC Chemistry

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina seeks a Senior Analyst 1, QC Chemistry to execute analytical methods for biological product manufacturing, including chromatography, spectroscopy, and electrophoresis, under GMP conditions.

You will ensure data integrity in LIMS, report assay performance, and assist CAPAs while training lab associates and contributing to method transfers and validations with cross-functional teams.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, biological sciences, engineering, or related field with 3+ years of experience.
• 3+ years of laboratory experience in GMP environment.
• Experience with analytical testing methods including chromatography, spectroscopy, electrophoresis, glycan analysis, etc.
• Experience with data capture in LIMS and maintaining data integrity.

Responsibilities

• Execute analytical testing methods used in biological product manufacturing (chromatography, spectroscopy, electrophoresis, etc.).
• Ensure testing of in-process, DS, DP, and stability samples complies with GMP.
• Capture analytical data in LIMS and ensure data integrity.
• Report assay performance and support improvements for quality and efficiency.
• Identify excursions and deviations and initiate CAPAs.
• Coordinate and support QC Chemistry lab activities.
• Provide training for QC Chemistry lab associates.
• Authors and reviews SOPs and technical reports.
• Collaborate with QC, Manufacturing, Process Science, QA to meet objectives.

Skills

Laboratory experience

GMP knowledge

Data integrity

Education

Bachelor’s degree in Chemistry/Biochem/Biology/Engineering

Master’s degree preferred

Tools

LIMS software

GMP laboratory equipment

Job description

The Senior Analyst 1, QC Chemistry works with limited direction to execute QC Analytical Chemistry methods used in biological product manufacturing, including chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Senior Analyst 1, QC Chemistry, adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identifies laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). The Senior Analyst 1, QC Chemistry is primarily responsible for executing routine analytical methods in support of manufacturing, supporting laboratory execution of analytical method transfers and validations, and training other QC Chemistry laboratory associates.

What You’ll Do

• Executes 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.
• Ensures analytical testing of in-process, drug substance (DS), drug product (DP), and stability samples is performed according to appropriate GMP regulations.
• Ensures analytical testing data is captured in LIMS software and data integrity is maintained.
• Reports assay performance and assists with implementing improvements that ensure quality and efficiency within QC Chemistry.
• Identifies and follows up on excursions and deviations and initiates corrective and preventative actions (CAPAs).
• Coordinates and supports QC Chemistry lab activities as needed.
• Provides training for QC Chemistry lab associates.
• Authors and reviews SOPs and technical reports.
• Works cross-functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Biotechnologies objectives.
• Performs other duties, as assigned.

Minimum Qualifications

• Bachelor’s Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience 1- 3 years relevant experience.
• 3+ years laboratory experience.
• 1-3 years GMP laboratory experience.
• 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 CESDS, 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

• Master’s Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field.
• 1+ years of experience with Raw Material methodology as it pertains to cGMP.