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Senior Associate (JP8119)

Cambridge, MA · Biotech/Pharmaceutical
Job Title:  Senior Associate (JP8119)
Location: Cambridge, MA. 02138 (Onsite Essential)
Employment Type:  Contract
Business Unit: Pivotal Attribute Science
Duration: 3 years
Posting Date: 1/19/20
 
 
3 Key Consulting is hiring a Senior Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:
  • 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.
 
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
 
 
Why is the Position Open?
Additional resource needed for supplemental workload.
 
 
Top Must-Have Skill Sets:
  • Experience in chromatography including HPLC, UPLC, and CE
  • Background with compendial methods testing, such as Karl Fischer, Color/Clarity, and UV/VIS spectroscopy
  • Understanding of phase-appropriate GMP compliance and documentation
 
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
 
 
 
Employee Value Proposition:
Working for a very dynamic team, gaining hands on knowledge and experience, ability to work on multiple programs.
 
Red Flags:
PhD Candidates would be overqualified for this role.
 
 
Interview process:
Video Skype Panel Interview
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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