Process Developement Associate

Job Summary

• 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.
  
  

location: Cambridge, Massachusetts

job type: Contract

salary: $20 - 24 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

Title: Process Developement Associate

Contract: 1 Year

Location: Cambridge, MA

• Shift: 8-hour day (flex start between 7-9 AM)
• 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.
  
  

Qualifications

• B.S. in Chemistry or Biochemistry
• 1-2 years of experience in a pharmaceutical/biotech analytical lab.
• Good general biochemistry laboratory skills
• Working knowledge of chromatography including HPLC, UPLC, and CE
• 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, Agilent softwares) 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
  
  

skills: Chemistry, Chromatography, GMP (Good Manufacturing Practice), Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Good Laboratory Practices (GLP)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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