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This position fulfills a critical role within BioProcess Engineering for upstream technology transfers, providing technical support and implementing process improvements at the Development Scale-up Center (DSC). The BioProcess Engineering department (within Research & Development) is responsible for production of materials for tox studies, process scale up, and transfers of processes to clinical and commercial manufacturing. Members of the DSC produce materials for toxicology and process scale-up studies, process performance confirmation, technology evaluations and troubleshoot issues in manufacturing facilities. Position Summary: This position is that of a scientific leader for the upstream process technology transfer function with the DSC team. The person in this role must have an in-depth background in process development, with emphasis on upstream process scale-up with knowledge of microbial fermentation and mammalian cell culture processes. Key responsibilities will include managing the technical relationship between DSC and development scientists, and performing process scalability assessments including fit-to-plant assessments and process risk analyses. The person in this role should be able to apply scientific knowledge and engineering principles, theories and concepts to assist scale-up of upstream operations such as cell expansion, production and harvest. The position will interface with development scientists, process engineers and manufacturing personnel to address production issues and to ensure that process equipment meet scalability requirements. Management: This position will have project management responsibilities; however, will not have people management responsibilities. The Manager/Senior Manager will provide feedback and input as part of annual performance and promotional processes.
This position can be filled at either the manager level or senior manager level. The individual is expected to possess strong technical skills and experience with biopharmaceutical upstream unit operations and equipment.
Education: A Bachelors, Masters or PhD degree in life sciences, biotechnology or chemical engineering or related field.
* The manager level position requires Bachelors with at least 10 years or Master with at least 8 years of combined industry experience.
* The senior manager level requires Bachelors with a minimum of 13 years or Masters with a minimum of 10 years or Ph.D. with at least 3 years of relevant industry experience.
Major Duties and Responsibilities: * Plans, designs, and executes projects within the cell culture, bioreactors, microbial fermentation and harvests technology. * Review, trend, analyze and interpret data to ensure consistent product quality and process performance. * Summarize and present run data, identification of scale-up constraints, and participation in continuous improvement projects.
* Acts as a project scientific leader when assigned and is recognized internally and externally as an expert in cell culture, bioreactor operations and harvest technology. * Makes detailed observations, analyses data, and interprets results * Proposes solutions to a wide range of difficult problems, requiring creative thinking skills. * Review production batch records for accuracy of transferred process information from upstream development sites to DSC. * Identify root causes for deviations, define corrective and preventative actions, implement innovative and/or replacement technologies, and analyze data to identify potential areas for improvement. * Proactively influence process decisions to avoid failures. Participate in the development and implementation of tools to improve process predictability. * Utilizes forward-looking perspective to contribute to “go/no go” decisions. * Makes recommendations on outside technologies for the department to pursue. * Scientific leadership of cross functional project teams, developing and implementing scientific strategy, and communication with project stakeholders to ensure timely delivery of successful project * Effectively presents results at internal meetings and external scientific meetings. * Perform other job related duties assigned.
Additional Notes * Strong scientific background in upstream process development, especially cell culture processes and fermentation. * Experience with operating bench, pilot, or production scale bioreactors/fermenters is required. * Proven experience in preparing detailed and thorough technical protocols and reports is required. * Good interpersonal skills and ability to interact with team members and cross-functional teams is required. * Familiarity with root cause analysis and problem-solving tools is a plus. * Position requires occasional evening or weekend work.
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.