• United States Of America, Usa
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  • 0 - 3 Years
  • Posted : above 1 month

Job Description:

MedImmune is the worldwide biologics research and development arm of AstraZeneca Here, youll have the opportunity to make a difference in peoples lives every day As one of the worlds 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, youll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives

Were 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 Were 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 were 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

Next Steps Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity If you know someone who would be a great fit, please share this posting with them

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 AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised

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

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Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Bio-Technology Research
Salary : As per Industry Standards
Deadline : 15th Mar 2020

Key Skills:

Company Profile:

Company
ASTRAZENECA PHARMA INDIA LTDarfix

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