Date posted 09/06/2019 If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us. MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. Here at MedImmune, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules. MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. Medimmune is seeking to recruit a Scientist I / II to join Physicochemical Development Department. The scope of the position and requirements are described below. Position Summary: The successful candidate will be responsible for analytical method developments and structure characterization of biopharmaceutical products, such as monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, fusion proteins, mRNA, DNA, and virus product (Newcastle disease virus (NDV) and Adeno-associated virus (AAV)). She / he will lead the development and improvement of analytical methods, which include, but are not limited to HPLC, CE and mass spectrometry. The candidate is expected to design, execute and manage laboratory studies both in-house and at CMO/CTLs for supporting clinical trial and product license application. Primary Responsibilities: Develop and optimize HPLC, CE, mass spectrometry and other protein analytical methods to support structural elucidation and physicochemical characterization of biopharmaceutical products. Serve as technical resource for analytical method issues, especially data interpretation, method troubleshooting and improvements. Drive the studies in-house to increase the understanding of candidate molecules and support the process development activities with cell line, cell culture, purification, conjugation, formulation and device development functions. Lead the method transfers and validation with CMOs/CTLs. Prepare and review QC SOPs, protocols, and reports related to product release, stability study, method validation, etc. Conduct developability study and collaborate with research colleagues on transition of new molecules to CMC development. Identify new analytical technologies and opportunities for improvement. Contribute to the investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results. Lead the preparation and review of CMC sections related to analytical procedures, method validation, specifications, reference standard and stability in INDs, IMPDs, MAAs, BLAs, and other regulatory submissions. Publish/present in high quality journals/conferences The candidate is expected to manage up associate scientist / research associates. Qualifications: Scientist I: BS 10+,MS 8+,PhD and some experience preferred Scientist II: BS 13+ MS 10+ PhD 3+ PhD Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific field. BS / MS Candidates with comparable experience will be considered. Expert experience in analytical methods such as mass spectrometry, HPLC (SEC-,RP-,IEX-,HIC-), CE (CE-SDS, icIEF), glycan analysis, SDS-PAGE, particle analysis, UV/Vis, FTIR, fluorescence spectrometry, circular dichroism (CD) and analytical ultracentrifugation is required. Analytical experience for mRNA, DNA, and virus product (Newcastle disease virus (NDV) and Adeno-associated virus (AAV) is highly preferred. Experience in cGMP (such as document management, deviation root-cause analysis, CAPA and change control) and QC practices including reference standard, control chart, stability, IOQ and validation is a plus. Working experience with CMOs/CTLs is a plus. Strong understanding in statistical analysis related to method development is a plus. Detail-oriented and capable of identifying and solving complex scientific problems. Ability to work independently in a fast-paced environment and drive multiple projects simultaneously. Strong interpersonal skills and excellent oral and written communication skill a must. Excellent teamwork is critical. Good multi-tasking, time management and organizational skills are essential. Supervisory, time/project management, and regulatory filing experience are desirable.Salary Range: NAMinimum Qualification11 - 15 years