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Scientist I, Analytical Development, Viral Vector Product Development

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Lexington, MA

Employer:  AstraZeneca
Job Type:  Full Time

Description

This is what you will do:

The candidate will play a key role in Alexion's analytical development team, interacting with the Genomic Medicine and Viral Vector Product Development groups. As a member of the analytical development team, you will support HPLC-based method development, qualification, and routine testing activities, and work cross-functionally to advance Alexion's genomic medicine portfolio. You will author reports and SOPs, along with contributions to our Regulatory Submissions.

You will be responsible for:
  • The development, optimization, and implementation of liquid chromatography-based methods to assess process impurities, surfactant quantitation, as well as capsid identity and peptide mapping of recombinant Adeno-Associated Virus (rAAV) and other viral vectors.
  • Lab activities such as design and execution of experiments, data review and analysis, and assay qualification.
  • Supporting tech transfer of HPLC-based assays to internal and external manufacturing/testing organizations for QC release and stability testing.
  • Developing presentations for internal and external audiences. Authoring and review of standard operating procedures (SOPs), technical reports, and assisting with the preparation of analytical sections for regulatory submissions (IND, BLA, etc.)
  • Group representation on cross functional teams which may include members of QC, Upstream/Downstream Process Development, Manufacturing, QA, and Regulatory.

You will need to have:
  • BS in Analytical Chemistry, Biochemistry, Molecular Biology or related field with 8+ years of relevant experience, a MS with 5+ years of experience, or PhD with 0 to 2+ years of experience.
  • The ideal candidate will have a strong background in biochemistry, analytical chemistry, or related fields, with hands-on experience in analytical characterization of viral vectors.
  • Direct experience with developing HPLC methods and performing analysis of AAV or other viral vectors. Hands-on experience with implementation of DOE and knowledge of mass spectrometry is highly desired.
  • Demonstrated ability to utilize standard office software (Excel, PowerPoint, Word, etc.), data analysis software (JMP, GraphPad, etc.), and eNotebooks software
  • Superior organizational and time management skills, ability to prioritize multiple demands and work efficiently under pressure.
  • Excellent interpersonal and communication skills are required, as well as the ability to work effectively in a cross-functional settings.
  • The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
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 authorization and employment eligibility verification requirements.
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