Scientist 2, QC Chemistry

Fujifilm-posted 3 months ago

Holly Springs, NC

Machinery Manufacturing

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The Scientist 2, QC Chemistry is a technical subject matter expert (SME) responsible for QC analytical chemistry 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 particle analysis, peptide mapping, and physical appearance, etc. The Scientist 2, QC Chemistry ensures GMP-compliant laboratory operations in accordance with regulatory guidelines. This role performs technical/compliance reviews and approves analytical results. The role approves laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). The QC Chemistry Scientist II authors, reviews, and approves SOPs, protocols, and technical reports. The role serves as the subject matter expert (SME) for QC Chemistry in cross-functional projects and meetings.

Performs physical and chemical analytical testing methods for biological products, 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.
Ensures analytical testing of in-process, drug substance (DS), drug product (DP), and stability samples is performed according to appropriate GMP regulations.
Performs laboratory work and peer reviews of analytical data in support of tech transfer and routine manufacturing.
Executes and reviews method qualification and validation activities and maintains lab equipment.
Monitors assay performance and implements improvements that ensure quality and efficiency within QC Chemistry.
Troubleshoots and investigates deviations and invalid assays performed in QC Chemistry.
Authors, reviews, and approves SOPs, protocols, reports, change controls, Trackwise deviations, out-of-specification (OOS) and out-of-trend (OOT) investigations, and CAPAs for the QC Chemistry team, as needed.
Represents QC Chemistry in cross-functional collaborations with other QC Departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives.
Manages and monitors lab activities as needed.
Provides training for QC Chemistry associates.
Provides technical support as the QC Chemistry SME during customer visits, audits, and regulatory inspections.
Participates in risk and gap assessments during project scoping as needed.
Authors technically-sound simple to moderately complex reports with limited guidance.
Collaborates with the LIMS team and IT department to build new method functionality that meets end-user and customer requirements.
Liaises with Contract Laboratory Organizations (CLOs) to monitor method execution and the timely delivery of results as needed.
Performs other duties, as assigned.

B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 9+ years of experience of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO)
4-6 years experience in a GMP environment
In-depth technical knowledge of physical and chemical analytical testing methods for biological products, 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.
Advanced knowledge of cGMPs, ICH, USP, EP, JP and FDA requirements as it relates to Chemistry analytical methods.
Familiarity with LIMS Software.

M.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 7+ years of experience, OR
Ph.D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of experience
Experience with Customer Relationship Management
Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting.
Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system)

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