Lead Scientist/Senior Scientist Mammalian Cell Culture Process Development
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 efforts for developing and optimizing cell culture processes 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.
▪ Execution of cell culture-based experiments including small scale cultures and pilot scale bioreactor operations
▪ Maintenance of laboratory preparedness including responsibilities for the PM, calibration, and operations of laboratory equipment
▪ Maintaining experimental records and compliance procedures for Good Laboratory Practice
▪ Able to thrive in a highly interactive and team-based environment
▪ Compilation, evaluation, and presentation of experimental data in oral presentations and written technical reports
▪ Tech transfer activities to manufacturing organizations
▪ PhD with a minimum of 6+ year(s) or BS/MS degree with a minimum 14+ years industrial experience and a degree in Chemical Engineering or related field.
▪ Must have hands on experience in process development utilizing CHO cells to produce biologics using deep well plates, shake flasks, and bioreactors
▪ Must have knowledge of Design of Experiments (DOE) and statistical analysis of data
▪ Must have a proven record of innovation and can apply scientific and engineering principles to solve complex problems
▪ A good understanding of cell physiology, metabolism, and cell biology
▪ Ability to multitask and adapt in a fast-paced environment and stay focused on project deliverables
▪ Work with minimum supervision in designing and executing experiments and analyzing data
Additional Desired Experience and Skills
▪ Knowledgeable in cell culture process scale-up and technology transfer to contract manufacturing organizations
▪ Working knowledge of GMPs and experience writing SOPs and batch records
▪ Medium development experience for CHO cell culture
▪ Experience with pilot scale bioreactors and primary recovery equipment