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Associate

Cambridge, MA

“This company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:            
  • Good general biochemistry laboratory skills
  • Working knowledge of chromatography including HPLC, UPLC, and CE
  • Background with compendial methods testing, such as Karl Fischer, Color/Clarity, and UV/VIS spectroscopy
Day to Day Responsibilities:        
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.

Summary
This company s Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces, and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers (“BiTEs”), live oncolytic viruses, and synthetic medicines.
Located in our Cambridge, MA office, the PD Associate Scientist (Process Analytics) will work to provide testing support for commercial process development and process characterization studies for clinical candidate molecules in the pivotal stage of development.

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 1 years of Scientific experience

Preferred Qualifications
B.S. in Biochemistry
  • Good general biochemistry laboratory skills
  • Working knowledge of 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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