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SalaryThis is what you will do:
The successful candidate will be a member of the Genomic MedicineDrug Product Development group within Injectable DPD. This individual will have a direct impact on a dynamic and growing group of scientists and engineers developing adeno-associated virus (AAV) based gene therapy products within the larger Alexion Rare Disease Business Unit organization.
This team member will implement studies for the development of AAV formulations, fill-finish processes, and clinical device compatibility to ensure clinical and commercial readiness.
You will be responsible for:
- Independent design and execution of formulation studies and non-GMP stability studies for AAV-based drug candidates.
- Administrative Device compatibility and In-use studies for clinical dosing enablement.
- Supporting development and tech transfer of GMP fill finish processes to internal and external manufacturing organizations.
- Developing and build presentations for internal and external collaborators
- Authoring of technical reports. Preparation of Drug Product sections for regulatory submissions (IND, BLA, etc)
- Group representation on, and leadership of, cross functional teams which may include members of AD, QC, Upstream/Downstream Process Development, QA, and Regulatory.
- Exciting opportunity to mentor junior group members!
You will need to have:
- PhD in Pharmaceutics, Biochemistry, Chemical Engineering, or relevant field with 2+ years experience, 11+ years with MS or 12+ years with BS
- Hands on experience developing stabilizing, clinically acceptable formulations and fill finish processes for biologics. Experience with development of AAV is highly valued.
- Comprehensive understanding of protein chemistry, formulation, degradation, and biopharmaceutical assays (CE, SEC, SVP analysis, DLS, etc.).
- Proven track record working cross-functionally with excellent interpersonal and Partnership ability!
- The duties of this role are generally conducted in an 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.
Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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. Join us in our unique and ambitious world.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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.
