What We Do:
Ambrx Biopharma, Inc. is a clinical-stage biologics company focused on discovering and developing a novel class of specific and selective engineered precision biologics, using our proprietary platform recombinant technology that allows site-specific incorporation of synthetic amino acids (SAAs) into proteins. Our product candidates are designed to overcome the inherent limitations of conventional conjugation approaches to optimize and maximize the therapeutic window of multiple immunotherapeutic candidates in oncology and other indications.
How will you contribute to our mission:
The Senior Scientist, Analytical Characterization and Development, will support our initiatives as a key member of the Pharmaceutical and Analytical Development team. The successful candidate will be primarily responsible for in-depth analytical characterization of mAb/protein, small molecule drug-linker intermediates, conjugated drug substance and final drug product, and working with Team members, CROs and CDMOs to accomplish project deliverables for pre-IND, IND, and BLA-enabling development.
- Develop and apply state-of-art technologies for detailed analytical characterization of complex protein molecules (including E. coli and CHO derived proteins/antibodies) and protein conjugates for research, process development, and clinical development.
- Lead efforts in drug-linker, mAb/protein, and ADC/protein conjugate testing and characterization involving small-molecule and impurity characterization; protein primary structural elucidation, PTM analysis and CQA evaluation, fractionation and detailed characterization of large-molecule impurities, conjugation site(s) and structural characterization.
- Work hands-on to develop and routinely test state-of-art analytical methods (LC/MS, MS/MS, peptide mapping impurity characterization, sequence variant analysis, glycan analysis, HPLC assays, CE-SDS, icIEF, etc.).
- Perform and oversee assay development, qualification/validation and method transfer to CDMOs/CROs to support clinical manufacturing, release and stability studies as well as analytical comparability studies.
- Write and diligently review analytical characterization and test methods, development reports, qualification protocols and reports, etc.
- Participate in project teams to provide analytical support and coordinate resources for new and ongoing projects, from research to clinical stages.
What you will need for consideration:
- Ph.D. in Analytical Chemistry with 6-8 yrs or MS with 10+ years of relevant industrial experience in analytical characterization of proteins and protein conjugates, method development and qualification.
- Essential hands-on experience and in-depth knowledge in instrumentation and modern analytical chemistry techniques of small molecules and proteins (peptide mapping, LC/MS and LC/MS/MS, CE-MS and CE-SDS, SE-HPLC, CEX-HPLC, RP-HPLC, HIC-HPLC, etc.).
- Experience with Agilent and Thermo mass spectrometer operation and maintenance; experience developing and applying 2D LC/MS/MS techniques for analysis of PTMs and identification of HCPs; expertise in comprehensive peptide and protein identification tools such as PepFinder and Byonic.
- Successful track record of overseeing Qualification/Validation of Analytical assays at CROs/CDMOs to meet timelines and stay within budget preferred.
- Knowledge of relevant ICH and FDA guidelines, USP Chapters and GMP compliance.
- Prior experience working with ADCs, bispecific molecules, and/or PEGylated proteins.
- Experience writing Characterization and Analytical methods sections of regulatory filings (INDs/IMPDs).
- Proven record in developing and applying new technologies for complex protein molecules, attention to detail in experimental design and data quality as well as excellent troubleshooting skills.
- Experience with assay development, qualification/validation and tech transfer to CDMOs to support clinical manufacturing.
- Excellent oral, presentation, and written communication skills, be able to communicate effectively with CMC and project teams, and CDMOs.
The pay scale for this position is $120,000-165,000 commensurate with experience. We believe this to be possible compensation for this role at the time of this posting, and we may modify this pay scale in the future.
As an equal opportunity employer, Ambrx is committed to a diverse workforce. Ambrx will consider all qualified applicants without regard to race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.