Associate Scientist, Analytical Development

Richmond, CA, United States
Aug 26, 2020
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
The Associate Scientist, Analytical Development is responsible for routine analytical test, project specific analytical method development, method qualification/validation and transfer throughout the biotherapeutic CMC project. The candidate will characterize, establish and monitor the purity, potency and structure of drug substances and products using various analytical techniques, including but not limited to HPLC, LC-MS, CE, SDS-PAGE, ELISA, UV/Vis spectroscopy. The Research Associate will work in a team environment with members of the analytical, process development and QC group.

Essential Duties and Responsbilities:

  • Responsible for routine analytical sample testing.
  • Responsible for project specific assay development/qualification and protein characterization.
  • Transfer method to QC for product release.
  • Technical support to manufacturing, Quality and QC during manufacturing and/or QC investigations.
  • Prepare and/or review written technical reports, SOPs, test methods, etc.
  • Maintain accurate and well-organized laboratory records and notebooks.

Required Experience / Skills

  • Master degree in Biochemistry, Chemistry or related discipline with 0-2 years' biological analytical development experience in pharmaceutical industry (or) bachelor degree with 0-4 years' experience. Job title will depend on education and related experience.
  • Experience with related techniques including but not limited to UV-Vis, HPLC, CE-SDS, cIEF, ELISA, light scattering, and Mass Spectrometry is a must.
  • Experience working with proteins, antibodies, and associated analytical methods is highly desired.
  • Knowledge of Chemstation software is a plus.
  • Knowledge of Good Laboratory Practices and/or Quality Control related cGMPs is a plus.
  • Ability to solve challenging problems.
  • Self-motivated, reliable team member.
  • Excellent written and verbal communication skills.

Location: Richmond, CA 94806

Work authorization: United States (Required)