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Associate Scientist/Scientist – Analytical /Formulation Development

Primary Responsibilities:

Job Responsibilities:

  • Act as a key expert in analytical and/or formulation development and/or product characterization for monoclonal antibodies (mAbs) and antibody drug conjugates (ADCs).
  • Carry out tests including, but not limited to, HPLC (RP, IEC, and HIC), CE-SDS, cIEF, DLS, SLS, MFI, glycan, peptide mapping and intact mass LC-MS, etc.
  • Compile scientific data, perform data analysis and interpretation, prepare technical reports, and present scientific data at project team meeting.
  • Develop, qualify, and transfer analytical methods, prepare SOPs and assay development reports, and provide troubleshooting as needed.
  • Identify, design, execute, and evaluate formulations for drug substance (DS) and drug product (DP) through thermo, conformational, and photo stability and solubility studies.
  • Collaborate and coordinate with colleagues in cell line, upstream, and downstream process development group.
  • Ensure adherence to GMP compliance as applicable.
  • Support drafting and review of regulatory filings and technical documents.

Job Requirements:

Qualifications:

  • BS, MS or Ph.D. in Biochemistry, Biophysics, Chemical Engineering, Biology, or other relevant scientific field with 0-5 years biopharmaceutical industry or academic experience in the characterization or method development or formulation development for mAbs or ADC.
  • Knowledge and experience in analytical methods: HPLC (SEC, RP, IEC, HIC, Protein A) and electrophoresis (CE-SDS and cIEF) is required. Experience in DLS, SLS, MFI, peptide mapping, intact mass LC-MS, disulfide bond mapping, and glycan profiling is preferred.
  • Knowledge and experience in current approaches for clinical phase appropriate formulation development is preferred.
  • Able to introduce and evaluate new technologies to improve the performance and efficiency of assays.
  • Strong technical competency in analytical and/or formulation development and troubleshooting for instrument failure, assay failure, or any testing failure.
  • Good understanding of cGMP regulations relevant to biotherapeutic drug product development.
  • Strong verbal and written communication skills and ability to manage multiple tasks simultaneously and pay attention to details.
  • Ability to work independently in a small company setting with limited operational support.

Benefits:

The company offers competitive benefits including medical, dental, vision and life insurance, as well as 401(k) match and paid time leave. SalubrisBio is an equal opportunity employer. To apply for this job, please contact Jinhua Feng (Jenny) at jinhua.feng@salubrisbio.com.