Job: 2023 – BR-05
Location: La Jolla, CA
Ambrx®, Inc. is an established biopharmaceutical company with a mission to deliver breakthrough protein therapeutics using an expanded genetic code. Unlike conventional conjugation techniques that create a mixture of suboptimal molecules, Ambrx technology combines site specific conjugation with proprietary linkers, payloads, and pharmacokinetic extenders to create a single molecular species that is optimized for safety, efficacy, and biophysical properties. We call this process Protein Medicinal Chemistry™.
Ambrx is seeking a highly motivated Senior Research Associate/Associate 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. Additionally, oversight of AFD activities at CDMOs and supporting regulatory filing source document preparation and organization is essential.
- 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) and related impurities; preliminary qualification of these test methods for protein therapeutic candidates in pre-clinical and early-phase clinical development.
- Characterize proteins and impurities utilizing conventional analytical techniques 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: buffer, pH, ionic strength, stabilizing excipients, surfactants, etc. Draft Summary Reports of studies.
- Perform long-term and accelerated stability studies; forced-degradation studies, material and clinical compatibility, and process/manufacturing change comparability studies.
- Summarize, interpret, and critically evaluate analytical data. Present results at Group, and Cross functional Team meetings.
- 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
- Proactively identify potential problems or opportunities in the context of project teams to facilitate advancement of product candidates.
- B.S in Biochemistry, Analytical Chemistry, Biophysics, or related field with 6+/10 years industrial experience in protein analytical method development or MS degree with 4+/7+ years. Industrial experience. The job title and compensation will be determined based on experience and knowledge of the candidate.
- Knowledge and hands-on experience with analytical method development and routine analysis of biologics using a wide range of physicochemical characterization techniques (including but not limited to): UV/Visible spectroscopy, HPLC (SEC, RP, IEX, HIC), CE-SDS, cIEF, DSC, DLS, HIAC, HCP analysis.
- Developability assessment of candidate protein therapeutics, and experience with late stage product development is desired.
- Knowledge and experience in developing and applying new technologies for complex protein molecules, excellent troubleshooting skills are required.
- Experience with liquid and lyophilized protein formulation development and conducting stability, compatibility and comparability studies.
- Independence in creating daily work flow, 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 email@example.com. 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.