Scientist 1, QC Analytical Development - Chemistry

Fujifilm•Holly Springs, NC

4d•Onsite

About The Position

The Scientist 1, QC Analytical Development Chemistry supports the 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. 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.

Requirements

In-depth technical knowledge of Analytical Chemistry and ability to analyze raw data, assess assay and system suitability criteria.
Demonstrated application and knowledge of ICH guidelines on analytical method validation.
Demonstrate communication skills, technical proficiency, scientific creativity, collaboration with others and independent thought.
Excellent interpersonal skills including the ability to work as part of a cross-functional team, collaborate with external clients, adapt to changing business needs, communicate with confidence, challenge others when necessary and display strong problem-solving capabilities.
Excellent English oral and written communication skills as well as demonstrated expertise with Microsoft Excel, PowerPoint, Word, etc..
Displays an advanced knowledge of GMP requirements for laboratory operations.
Possesses a broad knowledge of quality control operations, systems, and directives.
Must be flexible to support 24/7 manufacturing facility.
M.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.

Nice To Haves

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

Responsibilities

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.