Scientist, Analytical & Formulation Development

---

Job description

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 functional area, this individual should be able to maintain high standards of technical and quality excellence and may be tasked with providing day-to-day guidance for Associate Scientists and Research Associates in the lab.

Responsibilities:

• Develop analytical methods/assays ensuring that the projects are progressing as planned, process and products meet quality and regulatory requirements.
• Oversee and perform assay development, qualification/validation and method transfer to CMO/CRO to support clinical manufacturing, release, and stability studies.

• 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, comparability, forced-degradation, and stability studies.

• Oversee method performance, release and stability studies for Reference Standard, mAb, DS, DP at CMO.
• Develop and apply new technologies for analysis of complex protein molecules (including E. coli and CHO derived proteins/antibodies) and conjugates for research, process development, and clinical development.
• Write and diligently review analytical test methods, development reports, qualification protocols and reports.

• Lead efforts in protein and protein conjugates testing and characterization. Provide subject matter expertise across functions in research, research transitioning to development and product development stages.
• Participate in project teams to provide analytical support and coordinate resources for new and ongoing projects, from research to clinical stages.
• Maintain current knowledge of latest scientific and technical trends in the field.

Requirements:

• PhD. in Analytical Chemistry/Pharmaceutical Sciences or related field with at least 4 years of relevant industrial experience in analytical method development, formulation development and characterization of proteins. Exceptional non-PhDs with demonstrated capabilities and experience may also be considered.
• Must have essential hands-on experience and in-depth knowledge in instrumentation and modern analytical chemistry techniques of proteins (SEC, IEX, RP-HPLC, HILIC, affinity, SPE etc; LC/MS, peptide mapping, CE, spectrometry, biophysical assays such as DSC, DLS, HIAC etc.) applied to biologics. Experience with rigorous in-depth MS characterization of mAbs/ADCs is a plus.
• Significant experience with recombinant proteins, monoclonal antibodies, ADC, bi-specifics, and PEGylated proteins highly preferred.
• Must be able to demonstrate technical proficiency, scientific creativity, independent thought, and motivation.
• Proven record in developing and applying new technologies for analysis of 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/CDMOs to support clinical manufacturing.
• Prior experience with GMP-compliance and Quality/Regulatory Assurance is desirable.

Excellent oral, presentation, and written communication skills, ability to communicate effectively with cross functional team members, management, corporate functions and CMO/CDMOs.

To be considered for this opportunity, please submit your resume/CV referencing the position code. . Applicants whose qualifications and experiences most closely match the requirements will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensations & benefits. EOE.