- B.S. in Chemistry or Biochemistry
- Good general biochemistry laboratory skills
- Working knowledge of compendial methods testing, such as pH, Color/Clarity, Osmo, HIAC, and UV/VIS spectroscopy
- 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 compendial testing, such as pH, Visual Color, Visual Appearance, Turbidity, HIAC, Osmo.
- 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.
- Evaluation of novel platform methodologies to improve testing efficiencies in the Process Analytics and Rapid Analytics teams.
- Closely collaborate with partner organizations during commercial process development, process characterization and process validation studies to support marketing applications.
- B.S. in Chemistry or Biochemistry
- 1 year of Scientific experience
- Good general biochemistry laboratory skills
- Working knowledge of compendial methods testing, such as pH, Color/Clarity, Osmo, HIAC, and UV/VIS spectroscopy
- Working knowledge of chromatography including HPLC, UPLC, and CE
- 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) 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
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Entry Level Associate - Cambridge, United States - Ronin Staffing, LLC
Description
Job Description
Job DescriptionHERE'S THE JOB DESCRIPTION:
Title: Associate #12843
Pay Rate: up to $23.50/hr.
Location: Cambridge, MA 02138
Length: 5-6 month contract + possible extension
Top Must Have Skill Sets:
Job Summary:
The 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. The PD Associate (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.
Responsibilities:
Preferred Qualifications:
