Scientist I, Analytical Development, Viral Vector Product Development

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.

Date Posted

07-Jun-2024

Closing Date

08-Sep-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.