Sign upLog in

Associate Scientist

Compass Consulting

San Diego, CA

Apply
JOB DETAILS
SKILLS
Analysis Skills, Analytical Development, Analytical Method Development, Assay Development, Assay Methods, Assays, Cell Analysis, Cell Cultures, Clean Technologies, Communication Skills, Detail Oriented, Documentation, GMP (Good Manufacturing Practices), ICH Regulations, Laboratory Notebook, Laboratory Techniques, Process Analysis, Process Development, Product Testing, Quality Assurance Methodology, Quality Control, Reporting Skills, Research & Development (R&D), Standard Operating Procedures (SOP), Team Player, Test Plan/Schedule, Testing
LOCATION
San Diego, CA
POSTED
30+ days ago
Position Summary:

We are seeking an experienced and motivated Associate Scientist to join the Analytical Development team at Genentech San Diego. This position works with the PTCC team to develop and/or improve cell-based assays for cell
product characterization and release. The Analytical Development Associate Scientist participates in laboratory activities to support process development, evaluate and develop new assay methods, and perform product
characterization for CAR-T cell products. He/she is also involved in assay optimization and standardization and assay transfer to internal or external QC labs. Under the reasonable supervision, the role includes performing assay development experiments, carefully documenting methods and materials, writing SOPs/reports, and communicating findings. The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge in process and analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment.

Responsibilities:
  • Develops analytical test method procedures in accordance with relevant guidelines from ICH, USP, EP for cell therapy product GMP release testing and characterization.
  • Supports analytical routine testing, qualification, and validation.
  • Evaluates reagents and supplies to meet QC standards
  • Co-authors test methods (SOPs), technical reports, and analytical sampling plans
  • Documents laboratory procedures and experiments with great attention to detail in laboratory notebooks
  • Performs assays for process assessment and product characterization
  • Participates in assay transfers to QC and provides lifecycle support
  • Summarize and present scientific data to project teams.
  • Evaluates alternative technologies to create robust and reproducible analytical methods
  • Sets up, monitors, samples, and analyzes cell culture processes
  • Works with R&D teams to gain deeper understanding of the analytical methods for characterization of product critical quality attributes

About the Company

C

Compass Consulting

Resume Resources

Free Resume TemplatesFree Resume Builder