Development Scientist III, Viral Vector Analytical Development

AstraZeneca • Boston, MA

2d • $138,392 - $207,590 • Onsite

About The Position

Introduction to role: Are you ready to make a significant impact in the field of genomic medicine? As a Development Scientist III in Viral Vector Analytical Development at Alexion, you will be at the forefront of advancing our genomic medicine portfolio. Collaborate with a dynamic team of scientists and engage with the Genomic Medicine and Viral Vector Product Development groups to develop and optimize methods for assessing recombinant Adeno-Associated Virus (rAAV) viral vectors. Your expertise will drive innovation and contribute to regulatory submissions, ensuring the success of our cutting-edge therapies. Accountabilities: Develop, optimize, and implement biochemical and biophysical methods to quantify product and process impurities and perform extended protein characterization of rAAV vectors. Design and execute experiments, review and analyze data, and qualify assays in lab activities. Support tech transfer of biophysical assays to internal teams and external manufacturing/testing organizations for release and characterization testing; serve as subject matter expert for assay troubleshooting and lab investigations. Develop presentations for internal and external audiences, author and review SOPs, technical reports, and assist with analytical sections for regulatory submissions (IND, BLA, etc.). Serve as analytical lead on cross-functional CMC teams, collaborating with QC, Upstream/Downstream Process Development, Manufacturing, QA, and Regulatory teams to execute genomic medicine analytical strategy.

Requirements

• BS in Molecular Biology, Biochemistry, or related field with 10+ years of relevant experience, a MS with 8+ years of experience, or PhD with 4+ years of experience.
• Strong hands-on experience in the development, qualification/validation, and transfer of biochemical and biophysical (liquid chromatography, dynamic and multi-angle light scattering, capillary gel electrophoresis, imaged capillary isoelectric focusing) methods for assessing viral vectors and/or rAAV products.
• Demonstrated ability to utilize standard office software (Excel, PowerPoint, Word, etc.), data analysis software (Chromeleon, Empower, OpenLab, JMP, etc.), and eNotebooks software.
• Strong analytical mindset and problem-solving skills.
• Superior organizational and time management skills, ability to prioritize multiple demands and work efficiently with great attention to detail.
• Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment.
• The duties of this role are conducted in a mixed office and lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift 15 pounds unassisted; 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.

Nice To Haves

• Prior experience with mass spectrometry, surface plasmon resonance, mass photometry, analytical ultracentrifugation or other extended protein characterization techniques is a plus.
• Candidates should be self-starters, comfortable with autonomy, and embrace opportunities to develop new genomic medicines as part of a dynamic team within Alexion.
• When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.
• In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Responsibilities

• Develop, optimize, and implement biochemical and biophysical methods to quantify product and process impurities and perform extended protein characterization of rAAV vectors.
• Design and execute experiments, review and analyze data, and qualify assays in lab activities.
• Support tech transfer of biophysical assays to internal teams and external manufacturing/testing organizations for release and characterization testing; serve as subject matter expert for assay troubleshooting and lab investigations.
• Develop presentations for internal and external audiences, author and review SOPs, technical reports, and assist with analytical sections for regulatory submissions (IND, BLA, etc.).
• Serve as analytical lead on cross-functional CMC teams, collaborating with QC, Upstream/Downstream Process Development, Manufacturing, QA, and Regulatory teams to execute genomic medicine analytical strategy.

Benefits

• The annual base pay for this position ranges from $138,392 to $207,590.
• 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 pay (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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees