Quality Control Scientist

Your Role

At MilliporeSigma (CDMO) Cherokee, the Quality Scientist will perform quality control activities in support of GMP products within the stability and release ADC (antibody drug conjugates) team. This is an on-site role with work hours of 8:00 PM to 6:30 AM, Friday through Monday. The position will report to QC management.

• Perform analytical testing and other activities to support cGMP release, in process and stability testing of drug substances and drug products
• Provide complete and accurate records consistent with quality guidelines and good documentation practice (GDP) requirements
• Perform data review for GMP testing
• Test the in-process chemistry (protein concentration determination) and review in-process endotoxin (micro) data
• Ensure quality through adherence to GMP requirements
• Manage daily workload to consistently meet departmental deadlines and goals, proactively updating supervisors on operational status and escalating potential delays
• Participate in quality audits, as needed, providing complete and accurate records consistent with quality guidelines and GDP requirements
• Interface with customers and cross-functional departments as needed
• Train personnel and act as a technical consultant, leading process improvement initiatives
• Perform complex assays and processes requiring a higher level of skill and knowledge as well as identify problems and limitations of the analysis
• Perform advanced troubleshooting utilizing technical knowledge and theory
• Design basic experiments, evaluate data, and draw conclusions
• Provide logical explanations and potential solutions. Conduct training on complex analytical procedures
• Train and coach associates and senior associates within the team
• Contribute to support functions of the lab (e.g. maintain equipment, prepare reagents, restock lab supplies, and waste disposal)

Physical Attributes

• Perform tasks while wearing personal protective equipment such as chemical protective clothing, goggles, respirator, gloves, etc.
• Lift, push, and or pull up to 40 pounds

Who You Are

Minimum Qualifications

• Bachelor's degree in chemistry, Biochemistry, Biology or other life science discipline AND 10+ years' experience in analytical chemistry
• Master's degree in chemistry, Biochemistry, Biology or other life science discipline AND 5+ years' experience in analytical chemistry

Preferred Qualifications

• 5+ years of cGMP experience in pharmaceutical, biopharmaceutical or other life science industry
• Experience with ICE, Solo VPE, UV-Vis, KF, GC, LCMS, IC, CGE, and HPLC including Chromeleon software
• Strong technical writing and scientific reasoning
• Trackwise, Chromeleon, LIMS and SAP experience
• ELISA, Data Integrity, and ALCOA experience
• Strong command of Microsoft Excel, Word, Smart Sheets and Power Point
• Antibody Drug Conjugate (ADC) testing experience
• Experience in lean lab practices and continuous improvement initiatives
• Strong technical writing, root cause analysis and scientific reasoning
• Ability to excel in a dynamic team setting environment where shifting priorities are common