logo

View all jobs

Associate (JP9240)

Cambridge, MA · Biotech/Pharmaceutical
Job Title:  Associate (JP9240)
Location: Cambridge, MA. 02138
Employment Type:  Contract
Business Unit:  Pivotal AS
Duration: 2+ years (with likely extensions)
Notes:
Posting Date: 10/06/2021

3 Key Consulting is hiring an Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Client’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 their 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.

Why is the Position Open?
Additional workload on team.

Top 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.
 
  • 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

Employee Value Proposition:
  • Great Bio/Pharma to work for.
  • Grow their skillsets.

Red Flags:
PhD candidates.

Interview process:
Phone screening followed by in-person 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
 
 
Powered by