Scientist 1, QC Chemistry

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).