6701 Kaiser Dr Fremont, CA 94555
Analytical method development, qualification, and routine testing for characterization and stability activities for biopharmaceutical drug product programs.
Experience in analytical method development of potency assays in Process Science environment required. Cell based assays and binding assays utilizing Octet or Biacore methodology required. Biacore T200 strongly desired.
- Develop cell-based assays and bioassays for characterization and GMP lot release.
- Develop binding assays for characterization and GMP lot release.
- Perform routine sample testing following bioassay or binding test methods in non-GMP environment.
- Perform real time documentation, biostatistical analysis, data review and control charting as needed.
- Maintain mammalian cells and prepare cell banks as needed.
- Help maintain laboratory equipment, restock laboratory supplies, place orders, submit work orders and other routine tasks as needed.
Additionally, candidate will be expected to:
- Independently perform complex scientific experiments.
- Independently and efficiently troubleshoot complex scientific experiments.
- Assess and present analytical results in a clear manner.
- Work efficiently to complete assignments in a timely manner.
- 2-4 years of experience in analytical method development required.
- 2-4 years' experience with Biacore concentration assays.
- 2-4 years of experience with mammalian cell-based assays, preferably with reporter gene luciferase or T-cell activation assays.
- 2-4 years of experience with mammalian cell culture.
- Proficiency with Softmax Pro, MS Office.
- Candidate must possess strong analytical skills, attention to detail, the ability to multi-task and prioritize to deliver results in a fast-paced working environment.
- BS 4+ years in analytical method development
- MS 2+ years in analytical method development
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.