QC Analytical Development Chemistry Sr. Analyst I

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

 

Join us

 

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

 

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

About the Role

 

The QC AD Chemistry Sr. Analyst I 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 Diosynth Holly Springs (FDBN). 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 QC AD Chemistry Sr. Analyst I 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. The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.

 

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.

 

Minimum Requirements:

 

• B.A./B.S. degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline with 3+ years of experience.

• 3+ years laboratory experience

• 1-3 years GMP laboratory experience• Previous 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 p