Scientist/Senior Scientist, Analytical and Formulation Development
Ambrx is a biopharmaceutical company enabling a new field of protein medicinal chemistry, using a fundamentally new technology that directs incorporation of amino acids beyond nature’s conserved set into biosynthetic proteins to produce high value biologics products. Ambrx is seeking a highly motivated scientist to be a key member of a fast-paced and dynamic organization.
The successful candidate will be a valuable member in the Analytical and Formulation Development group at Ambrx. As a vital member of this function, this individual should be able to maintain high standards of technical and quality excellence and may be involved in managing Associate Scientist and Research Associates on a daily basis.
• Develop analytical methods/assays ensuring that the projects are progressing as planned, process and products meet quality and regulatory requirements.
• Work hands-on to develop and routinely test state-of-art analytical methods (HPLC assays, CE, icIEF, LC/MS, peptide mapping impurity characterization, glycan analysis, biophysical assays etc.); perform formulation development, compatibility, forced-degradation, and stability studies.
• Develop and apply new technologies for complex protein molecules (including E. coli and CHO derived proteins/antibodies) and conjugates for research, process development, and clinical development.
• Oversee and perform assay development, qualification/validation and method transfer to CMO/CRO to support clinical manufacturing, release and stability studies.
• Write and diligently review analytical test methods, development reports, qualification protocols and reports, etc. Oversee method performance, release and stability studies for Reference Standard, mAb, DS, DP at CMO.
• Provide expertise across functions in research, research transitioning to development and product development stages.
• Lead efforts in protein and protein conjugates testing and characterization, significant experience with recombinant proteins, monoclonal antibodies, ADC, bi-specifics, and PEGylated proteins highly preferred.
• Participate in project teams to provide analytical support and coordinate resources for new and ongoing projects, from research to clinical stages.
• Ph.D. in Analytical Chemistry/Pharmaceutical Sciences or related field with 4-8 yrs. or MS with 8-12 yrs. of relevant industrial experience in analytical method development, formulation development and characterization for proteins.
• Essential hands-on experience and in-depth knowledge in instrumentation and modern analytical chemistry techniques of proteins (SE-HPLC, CEX-HPLC, RP-HPLC etc; peptide mapping, LC/MS, CE, biophysical assays such as DSC, DLS, HIAC etc.) is required.
• 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 are required.
• Experience with assay development, qualification/validation and tech transfer to CMO to support clinical manufacturing. Prior experience in GMP-compliance and Quality/Regulatory Assurance is required.
• Excellent oral, presentation, and written communication skills, be able to communicate effectively with reports, management, corporate functions and CMO.
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits. EOE