Emergency / Absentee Backup:
The Senior Chromatography Specialist is responsible for chromatography instrumentation. The Senior Chromatography Specialist will work directly with the QC Manager and Lab supervisors to implement new methods, streamline existing methods, transfer of technology for routine testing, training QC Analysts on instrumentation and assist with getting new instrumentation operational for organic impurity analysis
Essential Duties and Responsibilities:
· Responsible for Liquid Chromatography and Gas Chromatography Instrumentation. Target instrumentation: HPLC, UPLC, and GC-MS/FID
· Maintenance and troubleshooting Chromatography Instrumentation in the laboratory
· Maintain inventory and storage of instrumentation accessories and equipment
· Develop and execute method feasibility on new products and streamline methods for existing products
· Responsible for method validation protocol generation, data review and assist with report generation in regards to chromatography instrumentation
· Assist with Review including validation data and notebooks for completeness and accuracy
· Assist with sourcing new instrumentation and getting it operational
· Function as an Organic Impurity Analytical Subject Matter Expert (SME)
· Knowledge of USP and ICH guidelines to ensure compliance
· Train QC analysts to perform analysis on the LC and GC instrumentation
· Assist with instrumentation change over from product to product analysis
· Transfer of technology from method validation to routine method analysis
· Perform organic impurity analysis to support regulatory submission
· Source and qualify if necessary reference standards for analysis
· Other duties may be assigned as deemed appropriate by management.
· Bachelor’s degree or higher in Science Field, Chemistry Degree or other related field and/or commensurate experience required.
· Experience in pharmaceutical or related industry in a laboratory setting, with knowledge of cGMP and related compliance regulations and guidance, is required.
· Ability to interpret data, perform complicated analytical calculations and statistical analysis
· Must be able to communicate technical, scientific, and regulatory information, both written and verbally
· Must be able to work in a cross-functional environment to interact with multiple departments
· Must be able to train QC analysis to perform organic impurity analysis.
· Prior experience in writing analytical protocols and reports
· Prior experience with organic impurity analysis, with a minimum of 3-5 years of direct hands-on organic impurity experience in a GMP laboratory is required.
· Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word
· Lift up to 20 lbs.
· Bend, stoop, carry, and reach
· Climb and/or stand on an elevated bench or step stool
· Sit and/or stand for extended periods
· Ability to see and distinguish color
· Work with chemicals and/or hazardous materials
Work Hours & Schedule:
· Exempt Position
· Minimum of 40-45 Hours Week, or other agreed upon documented schedule
· Ability and willingness to work from all BioSpectra facilities