Scientist I/II - Purification Process Sciences

AstraZeneca in Gaithersburg, MD

  • Industry: Scientific Research - Health/Medicine/Pharmacology
  • Type: Full Time
  • Compensation: $97,320.00 - 128,860.00 / Year*
position filled
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. Key Responsibilities Design, optimize, and characterize downstream processes for the manufacture of biopharmaceuticals such as antibodies and/or other recombinant molecules for clinical and commercial GMP manufacturingBe responsible for all or a significant portion of a purification development project(s)Working knowledge of AKTA systems/softwareCarry departmental representation and responsibilities in project CMC teamsMaintain records of experimental results, review, analyze and interpret data; Identify path based on sound scientific knowledge to move project forwardMake periodic presentations in group meetings, project team meetingsPrepare technical reports or other documents to support development and GMP activitiesSupport the preparation and review of regulatory documents such as INDs, IMPDs, BLAsContribute to process technology transfer to pilot/ clinical/commercial manufacturing facilitiesSupport troubleshooting and resolution of deviations in pilot and GMP manufacturing processesEvaluate new technologies to facilitate process developmentStay 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 Requirements Education/Experience 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. Knowledge of: Downstream purification methods including (but not limited to) different modes of chromatography, viral reduction steps and filtrationPrinciples of statistical design of experiments, process robustness concepts and process scale-upBasic analytical techniques (HPLC analysis, protein quantification methods, electrophoresis; etc.) Experience considered a plus: Viral clearance conceptsProcess development of biopharmaceuticals based on nucleic acids and gene therapy, including virus purification and in-vivo expressed biologicsMolecular modelling of separation methods Proficiency with a statistical software such as JMPTechnical writing in regulatory documents for biopharmaceuticalsConcepts of machine learning, molecular biology/ engineering, computer programmingcGMP manufacturing principles and environmentQuality by Design, risk-based assessments / prioritizationIn-silico predictive tools for protein behaviorHigh throughput techniques
Associated topics: clinical, dietary, food, immuno oncology, industrial hygienist, injury, pharmaceutical, toxicologist, vaccine, virus

* Estimated salary


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