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Job description
The Scientist 1, QC Chemistry is 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 1, 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).
What You’ll Do
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.
Participates in cross-functional collaborations with other QC Departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM 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.
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.
Executes routine analytical methods and trains other QC Chemistry laboratory associates.
Performs other duties, as assigned.
Knowledge, Skills or Abilities
Excellent oral and written communications skills and fluency in English; Good computer skills.
Excellent organization skills and attention to detail.
Ability to lead improvement projects.
Self-driven, dedicated, systematic, and able to plan projects and deliverables in a structured way.
Ability to analyze and present data and technical information to others outside of the team.
Ability to deliver independently, as well as provide guidance to QC team members. Initiator, motivator, mentor for other team members.
Ability to develop and assign tasks. Ability to develop structured plans.
Ability to solve complex challenges and assist others as needed.
Thinks strategically, ability to plan and implement improvements.
Passion for customers, ability to act as POC for clients in the laboratory.
Flexible, with a positive attitude, positive energy and seeks challenges and opportunities.
Ability to work cross-functionally with a diverse team and represent the department.
Must be flexible to support 24/7 manufacturing facility.
Minimum Qualifications
Bachelor’s in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of experience; OR,
Master’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.
Analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO).3+ years of experience working in a regulated GMP environment.
Knowledge and experience 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.
Preferred Qualifications
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 preventative action (CAPA), document management system).
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Worksite address
holly springs, NC, 27540, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.