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Sr Associate

Cambridge, MA
Top 3 Must Have Skill Sets:    

• Expertise in chromatography including HPLC, UPLC, and CE
• Experience performing mass spectrometry
• Background with compendial methods testing, such as Karl Fischer, Color/Clarity, and UV/VIS spectroscopy

Responsibilities:
• Transition of analytical methods from our early-stage development teams to the pivotal testing laboratory. This will include interfacing with attribute sciences team leads and early stage development teams, performing method assessment / qualification, method optimization, and formatting chromatography data software methods.
• Performing high-sample volume testing by High Performance Liquid Chromatography (HPLC), Ultra High-Performance Liquid Chromatography (UHPLC), Capillary Electrophoresis (CE), and Tecan in support of Drug Substance, Drug Product, and Attribute Sciences process development teams, under prescribed timelines. Full documentation of analyses in electronic lab notebook. Performing tracking and trend analysis of method performance.
• Hand-off/transfer of testing to our Rapid Analytics teams.
• Evaluation of novel platform methodologies to improve testing efficiencies in the Process Analytics and Rapid Analytics teams.
• Performing HPLC/UHPLC and CE method qualification studies to support transfer of methods to pivotal Quality Control teams.
• Perform forced degradation studies to support product characterization, understanding of product stability and evaluation of product comparability.
• Closely collaborate with partner organizations during commercial process development, process characterization and process validation studies to support marketing applications.

Basic Qualifications

Bachelor’s degree and 2 years of Scientific experience

Preferred Qualifications
• B.S. in Biochemistry
• Good general biochemistry laboratory skills
• Expertise in chromatography including HPLC, UPLC, and CE
• Experience performing mass spectrometry
• Background with compendial methods testing, such as Karl Fischer, Color/Clarity, and UV/VIS spectroscopy
• Strong desire to learn and interest in science
• Demonstrated proficiency in method development and experience with method technology transfer. Background in chromatography data software (Waters Empower®, Thermo Chromeleon®) and/or automation software (Tecan®)
• Understanding of phase-appropriate GMP compliance and documentation
• Well-organized; ability to multitask, effectively plan and follow through on complex projects, and to work both independently and in teams

"This posting is for Contingent Worker, not an FTE"
 

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