Sr Associate
360 Binney Street Cambridge, MA 02138 US
Job Description
*Depending on experience
Job Summary
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 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
• Performing high-sample volume testing by Liquid Chromatography (LC), Capillary Electrophoresis (CE), and wet chemistry methods in support of Drug Substance, Drug Product, and Attribute Sciences process development teams. Fully documenting analyses in electronic lab notebook. Performing tracking and trend analysis of method performance.
• 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, and formatting chromatography data software methods.
• Performing regular upkeep and periodic deep cleaning of laboratory instrumentation.
• Lead laboratory initiatives to improve workflow, execution, safety, etc.
• Closely collaborate with partner organizations during commercial process development, process characterization and process validation studies to support marketing applications.
Preferred Qualifications
• Bachelor of Science in Chemistry or Biochemistry with a minimum of 2 years of scientific experience working in the biotechnology/pharmaceutical industry OR a Master of Science in Chemistry or Biochemistry with expertise in analytical sciences
• Strong scientific knowledge
• Excellent laboratory skills
• Working knowledge of liquid chromatography and capillary electrophoresis
• Working knowledge of compendial methods testing, such as Karl Fischer, color/clarity, and UV/VIS spectroscopy
• Strong desire to learn and interest in science
• Demonstrated proficiency in execution of test methodology following a defined procedure.
• Background in chromatography data software (Waters Empower®, Thermo Chromeleon®, Chemstation) 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
Basic Qualifications
Master’s degree
OR
Bachelor’s degree and 2 years of experience
OR
Associate’s degree and 6 years of experience
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