Jobs · Quality Assurance · California

Associate Scientist, Analytical Development (Bioassay)

Bayside Solutions · San Mateo County, CA · 2 wk ago
On-siteQuality AssuranceContract

Location: South San Francisco, CA - Onsite. W2 Contract.

About the role

Job Summary: We are seeking a talented and experienced scientist to develop, optimize, and establish state-of-the-art potency assays for our diverse pipeline of large molecule biotherapeutics. The ideal candidate should have hands-on experience in ligand-based and cell-based bioassays to characterize activity and potency of a variety of modalities, including antibodies and Fc-fusion proteins, as well as potentially oligonucleotide-conjugates and virus-based gene therapies. The candidate will join a broader process development group with opportunities to closely collaborate on all aspects of analytical, formulation, and process development.

Responsibilities

  • Independently perform binding, enzymatic activity, ligand binding, and cell-based bioassays to support cell-line, bioprocess, and formulation development activities.
  • Assist in the development, optimization, and qualification of assays for product release and stability testing, as well as characterization of biological activity.
  • Support study sample testing, analysis, and maintain complete and accurate records, and contribute to continuing process improvement
  • Evaluate, characterize, and document critical reagents to meet QC standards.
  • Coordinate parallel tasks across multiple projects and prioritize deliverables to meet departmental and organizational goals.
  • Promote innovation and explore novel analytical techniques or technology.

Requirements and Qualifications

  • BS/MS with 5+ years of industry experience, with 2+ years of relevant experience in the industry
  • Hands-on experience within the development and optimization of bioassays (including cell-based assays) using multiple platforms and technologies (e.g., ELISA, HTRF, DELFIA, fluorescence, etc.) is required.
  • Experience in cell culture, including but not limited to cell passage and making of master cell bank and working cell banks of adherent and suspension cells.
  • Working with electronic notebooks and familiarity with graphing or statistical packages (GraphPad Prism, SoftMax Pro, PLA, etc.) is essential.
  • Ability to balance competing priorities and thrive in a dynamic, fast-paced environment
  • Excellent laboratory, critical thinking, scientific problem-solving, and organizational skills
  • Excellent oral and written communication skills
  • Motivated, detail-oriented, naturally curious individual with a creative approach to scientific problem solving and a burning desire to help patients with neurodegenerative diseases

Skills

  • Bioassay development and optimization, cell-based and ligand-binding assays, potency and biological activity testing, ELISA, HTRF, DELFIA, fluorescence assays, enzymatic activity assays, assay qualification, product release and stability testing, biotherapeutics and large molecules, cell culture, adherent and suspension cells, master and working cell banks, sample testing and data analysis, critical reagent characterization, QC documentation, electronic laboratory notebooks, GraphPad Prism, SoftMax Pro, PLA, cross-functional collaboration, scientific problem solving, project prioritization, BS/MS and 5+ years of industry experience

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