To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Job Description:

Job Roles & Responsibilities:

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

Basic Qualifications:               

• 0+ Years w/ Relevant MS OR equivalent 2+ Years w/ Relevant BS OR equivalent 4+ Years w/ Relevant AS OR equivalent 6+ Years

Top 3 Must Have Skill Sets:               

• B.S. in Chemistry or Biochemistry
• Good general biochemistry laboratory skills
• Working knowledge of liquid chromatography

Day to Day 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. 70% lab 30% office setting