Ambrx is a clinical-stage biopharmaceutical company with a mission to deliver breakthrough protein therapeutics through our proprietary technology. Unlike conventional conjugation technologies that creates a mixture of suboptimal molecules, Ambrx technology incorporates non-natural amino acids beyond the common twenty into the protein biosynthesis, enabling site specific conjugation of payloads, pharmacokinetic extenders with proteins to create novel homogenous molecular species that is optimized for safety, efficacy, and biophysical properties.

Ambrx is seeking a highly motivated Associate Scientist/Scientist to be a key member of the Analytical and Formulation Development team in a fast-paced and dynamic organization.  The successful candidate will be responsible for experimental design, performing routine analysis, data compilation, internal quality control, interpretation, and presentation of results for analytical and formulation development, characterization, compatibility, comparability and stability studies.

Major Responsibilities:

  • Contribute to the design and conduct analytical method development and formulation development experiments for complex protein biomolecules including E. coli, and CHO derived proteins, antibodies, ADC, and PEGylated Proteins.
  • Develop and routinely conduct state-of-art analytical testing (HPLC assays, CE, icIEF, peptide mapping impurity characterization, glycan analysis, biophysical assays etc.) for compatibility, forced-degradation, and stability studies.
  • Characterize proteins and impurities utilizing conventional analytical techniques, mass spectrometry support, and specialized biophysical methods to understand degradation pathways and improve protein stability.
  • Analytical method development, optimization, and pre-qualification to establish robust methods for transfer to CMOs; write standard test methods and review qualification protocols and reports, and trend stability data.
  • Contribute to the design and conduct pre-formulation and formulation development and optimization experiments: Draft Summary Slides/Reports of studies.
  • Perform long-term and accelerated stability studies; forced-degradation studies, material and clinical compatibility, and process/manufacturing change comparability studies.
  • Provide analytical support for cell line development, upstream, downstream, conjugation process development, and analytical method transfer to CMOs.
  • Manage stability data, generate trend plots, track OOS and OOT results and assist with any deviations and investigations
  • Summarize, interpret, and critically evaluate analytical data. Present results at Group, and Cross functional Team meetings.

Job Qualifications:

  • B.S in Biochemistry, Analytical Chemistry, Biophysics, or related field with 7+ years industrial experience in protein analytical method development, or MS degree with 5+ years Industrial experience, or a PhD with relevant experience. The job title and compensation will be determined based on experience and knowledge of the candidate.
  • Essential hands-on experience and in-depth knowledge in instrumentation and modern analytical chemistry techniques of proteins (SE-HPLC, CEX-HPLC, RP-HPLC, icIEF, etc; peptide mapping, CE, biophysical assays such as DSC, DLS, HIAC etc.) is required.
  • Experience with assay development, qualification/validation, and tech transfer to CDMO to support clinical manufacturing. Prior experience with LC/MS and QC/QA is a plus.
  • Knowledge and experience in developing and applying new technologies for the analysis of complex protein molecules, attention to detail in experimental design and data quality as well as excellent troubleshooting skills are required.
  • Experience with liquid or lyophilized protein formulation development and conducting stability, compatibility and comparability studies.
  • Independence in creating daily workflow, experimental execution and data analysis is required.
  • Excellent organization and team spirit, oral, written, and interpersonal communication skills to work well across scientific disciplines.

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code to Applicants whose qualifications and experiences most closely match the requirements will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits. EOE.