Scientist I, QC Analytical Development - Chemistry

Position Overview

The Scientist 1, QC Analytical Development Chemistry supportsthe transfer of analytical Chemistry methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth, Holly Springs (FDBN). The Scientist 1, QCAD ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. The Scientist 1, authors transfer documents and executestesting as part of transfer for the following analytical methods: HPLC/UPLC chromatography (Protein A/G titer, SEC, PS80, glycans, peptide map); UVA280 and slope spectroscopy; capillary  electrophoresis (CE-SDS, imaged capillary isoelectric focusing (icIEF)); general pharmaceutical properties methods.

Company Overview

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

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

 

Job Description

What You'll Do

 

• Supports analytical chemistry method tech transfer and execution through method verification, transfer, and validation.• Interfaces with customers and program management to identify analytical needs and method gaps during project scoping• Participates in meetings for TT programs with cross-functional teams and key stakeholders• Authors technical documents including transfer and validation protocols / reports• Communicates with QC testing teams, Quality Assurance (QA), and Process Science groups to ensure prioritization of non-compendial and compendial method transfer activities 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 QCAD team to investigate any project challenges with necessary risk assessment tools and techniques• Supports best practices for TT and PPQ strategies globally, as required• Performs other duties, as assigned

 

Minimum Requirements:

 

• B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 6+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO) OR• M.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 4+ years of experience, OR• Ph.D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 2+ years of experience• Experience with analytical method transfers• Experience with project management and demonstrated ability for providing regular updates and escalations• Proficient in physical and chemical testing methods for biological products, including HPLC/UPLC chromatography (Protein A/G titer, SEC, PS80, glycans, peptide map); UVA280 and slope spectroscopy; capillary electrophoresis (CE-SDS, imaged capillary isoelectric focusing (icIEF)); general pharmaceutical properties methods.• 1-3 years of experience in a GMP environment• Relevant experience in analytical method development, transfer, and validation

 

Preferred Requirements:

 

• Experience with Customer Relationship Management• Prior drug substance experience, including analytical method validation, transfer, commercialization, and manufacturing support and troubleshooting