Scientist 1, QC Analytical Development - Chemistry

Fujifilm • Holly Springs, NC

6h • Onsite

About The Position

The Scientist 1, QC Analytical Development Chemistry supports the transfer of analytical chemistry methods for technology transfer of drug substance and drug product into FUJIFILM Biotechnologies’ Quality Control laboratories in Holly Springs, North Carolina. The role helps ensure GMP-compliant laboratory operations in accordance with regulatory guidelines and authors transfer documents and performs testing for methods including HPLC/UPLC chromatography (Protein A/G titer, SEC, PS80, glycans, and peptide map), UVA280 and slope spectroscopy, capillary electrophoresis (CE-SDS and icIEF), and general pharmaceutical properties methods.

The position supports analytical chemistry method verification, transfer, and validation; works with customers, program management, and cross-functional teams to identify analytical needs and method gaps; and coordinates transfer priorities with QC, QA, and Process Science. It also develops technical transfer and validation documents, supports regulatory requests and inspections, collaborates on LIMS and IT functionality, and contributes to project risk assessment and global technology transfer and PPQ practices. The role requires flexibility to support a 24/7 manufacturing facility.

FUJIFILM Biotechnologies is developing a biopharmaceutical manufacturing facility in Holly Springs, North Carolina, with drug substance production, fill-finish, and packaging capabilities. The posting describes a dynamic work environment and the company’s Genki culture.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or a related science field and 5 or more years of analytical laboratory experience, preferably in biotechnology, Pharma, CRO, or CLO; or a master’s degree in one of those fields and 3 or more years of experience; or a doctoral degree in one of those fields and 1 or more years of experience.
• Experience with analytical method transfers.
• Experience with project management and demonstrated ability to provide regular updates and escalations.
• Proficiency in physical and chemical testing methods for biological products, including HPLC/UPLC chromatography (Protein A/G titer, SEC, PS80, glycans, and peptide map), UVA280 and slope spectroscopy, capillary electrophoresis (CE-SDS and icIEF), and general pharmaceutical properties methods.
• At least 3 years of experience working in a regulated GMP environment.
• Relevant experience in analytical method development, transfer, and validation.
• In-depth technical knowledge of analytical chemistry and ability to analyze raw data and assess assay and system suitability criteria.
• Demonstrated knowledge and application of ICH guidelines on analytical method validation.
• Communication skills, technical proficiency, scientific creativity, collaboration, and independent thought.
• Interpersonal skills, including ability to work on cross-functional teams, collaborate with external clients, adapt to changing business needs, communicate confidently, challenge others when necessary, and solve problems.
• Excellent English oral and written communication skills.
• Demonstrated expertise with Microsoft Excel, PowerPoint, Word, and related tools.
• Advanced knowledge of GMP requirements for laboratory operations.
• Broad knowledge of quality control operations, systems, and directives.
• Flexibility to support a 24/7 manufacturing facility.

Nice To Haves

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

Responsibilities

• Support analytical chemistry method technology transfer and execution through method verification, transfer, and validation.
• Interface with customers and program management to identify analytical needs and method gaps during project scoping.
• Participate in technology transfer program meetings with cross-functional teams and key stakeholders.
• Author technical documents, including transfer and validation protocols and reports.
• Communicate with QC testing teams, QA, and Process Science groups to prioritize non-compendial and compendial method transfer activities according to deadlines.
• Collaborate with the LIMS team and IT department to build analytical method functionality that meets end-user and customer requirements.
• Ensure compendial method oversight and follow scientific guidelines, including ICH, EMA, and FDA guidelines.
• Support regulatory requests and inspections.
• Support the QCAD team in investigating project challenges using appropriate risk assessment tools and techniques.
• Support global best practices for technology transfer and PPQ strategies, as required.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level