Scientist I/II - Purification Process Sciences
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration through scientific research. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.
Location - (Gaithersburg, MD)
Position is a hands-on, laboratory-based role.
- Design, optimize, and characterize downstream processes for the manufacture of biopharmaceuticals such as antibodies and/or other recombinant molecules for clinical and commercial GMP manufacturing
- Be responsible for all or a significant portion of a purification development project(s)
- Working knowledge of AKTA systems/software
- Carry departmental representation and responsibilities in project CMC teams
- Maintain records of experimental results, review, analyze and interpret data; Identify path based on sound scientific knowledge to move project forward
- Make periodic presentations in group meetings, project team meetings
- Prepare technical reports or other documents to support development and GMP activities
- Support the preparation and review of regulatory documents such as INDs, IMPDs, BLAs
- Contribute to process technology transfer to pilot/ clinical/commercial manufacturing facilities
- Support troubleshooting and resolution of deviations in pilot and GMP manufacturing processes
- Evaluate new technologies to facilitate process development
- Stay generally current with biopharma industry state-of-the-art technology, trends, events, etc.
- Be highly team oriented, organized, capable of significant multitasking, able to manage multiple projects with significant independence
Scientist I: Ph.D. Degree in Biochemistry, Chemical Engineering, or related field and some relevant experience preferred.
Scientist II: Ph.D. Degree in Biochemistry, Chemical Engineering, or related field, with a minimum of 3 years of relevant experience.
- Downstream purification methods including (but not limited to) different modes of chromatography, viral reduction steps and filtration
- Principles of statistical design of experiments, process robustness concepts and process scale-up
- Basic analytical techniques (HPLC analysis, protein quantification methods, electrophoresis; etc.)
Experience considered a plus:
- Viral clearance concepts
- Process development of biopharmaceuticals based on nucleic acids and gene therapy, including virus purification and in-vivo expressed biologics
- Molecular modelling of separation methods
- Proficiency with a statistical software such as JMP
- Technical writing in regulatory documents for biopharmaceuticals
- Concepts of machine learning, molecular biology/ engineering, computer programming
- cGMP manufacturing principles and environment
- Quality by Design, risk-based assessments / prioritization
- In-silico predictive tools for protein behavior
- High throughput techniques
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.