Associate Scientist, Cell Culture Bioreactor Process Development
Contribute to mammalian cell culture process development and operation at Altor Bioscience to optimize and validate existing clinical product manufacturing processes and develop and characterize upstream processes of novel recombinant proteins for transfer to clinical/commercial manufacturing.
Specific Duties and Responsibilities:
- Timely execution of all aspects of upstream mammalian cell culture operations, including cell expansion and fed-batch/perfusion methodologies, assembly, sterilization, calibration, operation and control of small scale single use and glass bioreactors, analysis of cell growth, metabolic activity and productivity and methods for harvest clarification
- Perform process optimization and validation based on design of experiment approaches of upstream processes for existing clinical products in preparation for Phase 3/commercial manufacturing
- Support the development of upstream processes for novel pipeline products and monoclonal antibodies for research and development efforts
- Compile data to support/contribute to technical/development reports for technology transfer and regulatory submission
- Support technology transfer to contract manufacturing organizations
- Develop and perform analytical methods on cell culture media to support process development
- Support troubleshooting of technical issues and process improvement for higher efficiency
- Maintain scientific excellence and attention to detail
- Work collaboratively with project teams to advance Company goals
- Understand the job specific quality system and processes as defined by the company’s SOPs and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager.
- Maintain corporate confidentiality at all times.
- M.S. degree in biotechnology, bioengineering, biomanufacturing or biomedical engineering from a top twenty US university or the international equivalent.
- Minimum one year of accumulative working experience in a pharmaceutical or bioscience/biotechnology industry with emphasis in upstream process development with emphasis in mammalian (CHO) cell culture processes
- Strong background in Pharmaceutical/Biotech industry
- Candidates with research experience preferred
- Knowledge of Design of Experiment approaches for process optimization