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, Holly Springs (FLBN). This role ensures Good  Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. The Scientist 1, QC Analytical Development Chemistry authors transfer documents and executes testing 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.

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 5+ 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 3+ years of experience, OR• Ph.D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 1+ 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.• 3+ years of experience working in a regulated GMP environment

• Relevant experience in analytical method development, transfer, and validation

 

Preferred Requirements:

 

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

 

Physical and Work Environment Requirements:

 

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 wrists, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Will work in warm/cold environments (5 C)

Will work in small and/or enclosed spaces.