Scientist I, Analytical Development, Viral Vector Product Development (Protein Characterization)

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 process analytics team, you will support the routine testing of AAV products, develop and refine methods, and work cross-functionally to advance Alexion’s genomic medicine portfolio. You will also review data, author technical reports and SOPs.

You will be responsible for:

• Testing of samples involving liquid chromatography and capillary electrophoresis methods to assess product purity, aggregation, and product/process related impurities of recombinant Adeno-Associated Virus (rAAV) viral vectors.
• Analytical activities such as design and execution of experiments, data review and interpretation, communication of testing results, and assay qualification.
• Aid in coordination of all process development and research testing needs including sample management, prioritization, training, and troubleshooting.
• Support of laboratory-based operations: generation and maintenance of reference material, data trending, reagent and sample inventory and equipment maintenance.
• Supporting tech transfer of HPLC and CE-based assays to internal and external manufacturing/research organizations for QC release and stability testing.
• As required, present to internal and external audiences. Author and review of standard operating procedures (SOPs), technical reports, and other relevant internal documents.
• Group representation on program cross functional teams which may include members of Upstream/Downstream Process Development, Manufacturing, QC, 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 3+ 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.

• Experience in the operation or oversight of laboratory operations, in terms of sample testing, inventory and equipment maintenance.
• Direct experience with developing HPLC and CE methods and for the analysis of AAV or other viral vectors. Experience in technologies that assess empty-full ratios (AUC, mass photometry, CD-MS etc.) would be ideal.
• Firsthand experience with automation and implementation of DOE and assay qualification is highly desired.
• Proven track record to utilize standard office software (Excel, PowerPoint, Word, etc.), data analysis software (JMP, GraphPad, etc.), and eNotebooks software.
• Strong organizational and time management skills, ability to prioritize multiple demands and work efficiently under pressure.
• Experience understanding the needs of other functions within TechOps/CMC and planning/coordinating testing and development activities to meet the needs of the program team.

• Excellent interpersonal and communication skills are required, as well as the ability to work effectively in a cross-functional setting.
• The duties of this role are mostly 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; PPE gowning; use of 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.

The annual base salary (or hourly rate of compensation) for this position ranges from $110,687.20 to $166,030.80. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

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.