Ambrx is a clinical-stage biopharmaceutical company enabling a new field of protein medicinal chemistry, using a technology that directs the incorporation of amino acids beyond nature’s conserved set into biosynthetic proteins to produce high value biological products such as antibody-drug conjugates. Ambrx is seeking a highly motivated scientific leader to be a key member of a fast-paced and dynamic organization.
This position will focus on upstream process development and lead the efforts for developing and optimizing the cell culture process including medium development, feeding strategies, process parameter optimization, process characterization and scale-up for large scale production to support R&D, pre-clinical, and clinical activities. This individual will design and carry out experiments and provide technical leadership and serve as the subject matter expert on project teams and work closely with other groups to provide support for the Company’s projects. The candidate will monitor, explore and evaluate next generation technologies to speed up process development. This individual will also be responsible for technology transfer to third parties including partners and CMO and will serve as the person-in-plant for manufacturing activities. The role will involve authoring of development reports and CMC sections for regulatory submissions including INDs and BLAs.
• Ph.D with 12+ yrs industry experience or MS with 16+ yrs industry experience in Biochemical Engineering, Chemical Engineering, Biochemistry or related field
• Hands-on experience with CHO and other mammalian cell for mAb or recombinant protein production is a must
• Hands-on experience using spin tubes, shake flasks, and bioreactors is required
• Previous experience in cell culture scale-up, tech transfer including drafting development reports, production batch records, protocols and Knowledge of scale-up and scale-down models is highly desired.
• Knowledge of statistical design of experiments in process development and optimization
• Previous experience in cell culture media development and cell culture platform development is plus
• The ability to succeed in a multidisciplinary, fast changing and diverse team environment
• Working knowledge of GMP and experience with US IND/BLA filings are highly desirable
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code. 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