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Provide training, troubleshooting, and oversight of high performance liquid chromatography (HPLC) analyses; Analyses include size-exclusion, cation and anion exchange, affinity, and reversed phase high performance liquid chromatography and/or ultra high performance liquid chromatography (UHPLC); Perform hands-on testing support of the HPLC/UHPLC methods; Implement new HPLC/UHPLC methods including, drafting test method standard operating procedures, performing familiarization runs, and documenting method establishment in method transfer reports; Perform and trend assay control charts to monitor the performance of all HPLC/UHPLC testing; Interface with analytical method developers and team leads on method performance; Perform technology development to improve the speed and compliance; Qualify HPLC/UHPLC methods to enable transfer of methods to a quality control laboratory; and Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications. May telecommute. Supervises direct reports.
Job Responsibility
Provide training, troubleshooting, and oversight of high performance liquid chromatography (HPLC) analyses
Analyses include size-exclusion, cation and anion exchange, affinity, and reversed phase high performance liquid chromatography and/or ultra high performance liquid chromatography (UHPLC)
Perform hands-on testing support of the HPLC/UHPLC methods
Implement new HPLC/UHPLC methods including, drafting test method standard operating procedures, performing familiarization runs, and documenting method establishment in method transfer reports
Perform and trend assay control charts to monitor the performance of all HPLC/UHPLC testing
Interface with analytical method developers and team leads on method performance
Perform technology development to improve the speed and compliance
Qualify HPLC/UHPLC methods to enable transfer of methods to a quality control laboratory
Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications
Supervise direct reports
Requirements
Master’s degree in Chemistry, Biochemistry, Analytical Chemistry, or related field and 3 years of experience in the job offered or in a chemistry-related occupation
Developing, executing, and troubleshooting analytical test methods utilizing high performance liquid chromatography
Qualifying and transferring analytical test methods following pharmaceutical industry guidelines
Operation and data analysis with chromatography data software such as Waters Empower, Agilent Chemstation, or OpenLab
Investigating out of trend and out of specification analytical test results
Training analysts on the operation of high-performance liquid chromatography equipment and the interpretation of chromatography data for biological and small molecule drug candidates
Executing analytical tests in accordance with the United States or international pharmacopoeia.
What we offer
stock
retirement
medical
life and disability insurance
annual bonus
flexible work models including remote and hybrid work arrangements