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 bioassay scientist to be a key member of the Translational Sciences team. The successful candidate will be primarily responsible for developing ELISA and cell-based potency assays for antibody drug conjugates (ADCs) and managing GMP CROs.
• Develop and pre-qualify cell-based potency assays and antigen binding ELISA methods.
• Apply Design of Experiments (DOE) to identify and optimize critical assay parameters.
• Set stage-appropriate systems suitability and acceptance criteria.
• Utilize PLA 3.0 software to perform parallel line analysis (equivalence testing).
• Interview GMP CROs, negotiate quotes, and perform audits to evaluate technical capabilities.
• Manage CROs to ensure bioassay methods are transferred and qualified within timelines for GMP lot release testing.
• CRO oversight to ensure stability sample testing occurs within specified time frames, new critical reagent lots are qualified for use, and any deviations, investigations, or CAPAs are resolved.
• Monitor bioassay performance and trend GMP DS and DP batch stability data.
• Represent bioassay function at project CMC subteam meetings.
• Perform non-GMP potency assay sample testing to support program needs.
• Write Development reports, memos, and relevant CMC sections for regulatory submissions.
• Present work and effectively communicate progress at meetings.
• Ph.D. (or MS) in Cell Biology or a related scientific discipline with >3 years of industry experience in the bioassay field. (title commensurate with experience)
• Extensive, hands-on experience in bioassay methods optimization, qualification, and validation.
• Prior experience auditing and managing GMP CROs for bioassay testing.
• Proficient at using JMP, Design of Experiments (DOE), and PLA 3.0 software.
• Knowledge of relevant ICH and USP chapters, GMP requirements, and industry best practices.
• Demonstrated capability to work with team members to troubleshoot and identify solutions.
• Prior experience working with ADCs or bispecific molecules is desirable.
• Ability to work effectively in a goal-oriented, fast-paced, matrixed team environment.
• Flexibility to contribute to other functional areas is desirable.
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