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Scientist/Sr. Scientist, Analytical

CEDENT

San Diego, CA

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JOB DETAILS
SKILLS
Analysis Skills, Analytical Development, Analytical Method Development, Assays, Biochemistry, Biological Assay, Biotech and Pharmaceutical, Cell Analysis, Chemical Engineering, Chemistry, Chromatography, Communication Skills, Cross-Functional, High Performance Liquid Chromatography (HPLC), Identify Issues, Investigational New Drug (IND), Leading Edge Technology, Polymerase Chain Reaction (PCR), Pre-Clinical, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Product Development, Quality Control, Regulatory Submissions, Sales Qualification, Standard Operating Procedures (SOP), Testing, Writing Skills
LOCATION
San Diego, CA
POSTED
30+ days ago
Client is seeking an Analytical Scientist/Senior Scientist (level dependent on experience) to join the Analytical Development Team. The Scientist/Senior Scientist will be responsible for developing, performing, and qualifying analytical methods in support of cellular nanoparticle platform based new product development for DS/DP and in-process samples. This is a multi-functional role in an agile and fast-paced environment, working on a novel and differentiated cellular nanoparticle technology.

Some of the Essential Duties and Responsibilities
  • Independently design, develop and troubleshoot analytical assays, including but not limited to nanoparticle analysis, lipid analysis, potency assays, ELISA, Western Blot, PCR-based assays, flow cytometry.
  • Lead analytical method development and optimization for biological substances and nanoparticles.
  • Lead method qualification/ validation and transfer to QC team.
  • Proactively drive collaboration with internal and external partners to design and execute analytical studies in support of process development, stability, pre-clinical, and clinical programs.
  • Serve as subject matter expert in cutting-edge technologies and platforms used for bioanalysis and nanoparticle characterization.
  • Perform analytical testing to support DS/DP characterization and process development.
  • Proactively identify assay issues and assay needs to support the company pipeline projects.
  • Author and review corresponding CMC sections in regulatory filings and responses.
  • Author and review assay SOPs, analytical study/qualification protocols and reports.
Qualifications
  • Ph.D. in Biochemistry, Chemistry, Chemical Engineering or related discipline with 2+ years of experience, or M.S. with 5+ years of experience in Biotechnology or Pharmaceutical Industry.
  • Experience in chromatography and other biophysical methods (HPLC/UPLC/CE, DLS, Nanosight, Flow Cytometry, etc.) highly desirable.
  • Hands-on experience in cell-based analytical methods and biologic product characterizations highly desirable.
  • ELISA, Western Blot, PCR-based methods and other bioassay experiences highly desirable.
  • Experience with TFF or microfluidizer is desirable.
  • In-depth knowledge in lipid nanoparticle (LNP) for drug delivery highly desirable.
  • Experience in biologics regulatory submissions (IND, BLA) desirable.
  • Excellent problem-solving skills and verbal and written communication skills.
  • Self-motivated and able to thrive in a dynamic environment.
  • Open-mindedness to learn and share professional knowledge and experience.

About the Company

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