Engineer - Downstream, Viral Vector Product Development
This is what you will do:
The candidate contributes to the Viral Vector Product Development group through the design and execution of experiments based around downstream AAV (Adeno-Associated Virus) manufacturing processes. They will assist the purification team to generate, interpret, and present experimental data to inform and recommend process operating conditions with the goal of developing a robust and scalable manufacturing process. They will additionally draft documentation and provide expertise to assists in scale-up and tech transfer to clinical/commercial manufacturing facilities as well as submission of regulatory filings.
You will be responsible for:

• Support the downstream development of AAV manufacturing processes to optimize the viral vector purification steps (chromatography, filtration, UF/DF)
• Perform OFAT and DoE-directed experiments to identify key and critical process parameters and to identify and recommend acceptable ranges for process scale-up and tech transfer
• Document experiments, compile analytical data, and summarize findings in lab notebook entries and reports
• Support tech-transfer of manufacturing processes to external partners. At times provide person-in-plant (PIP) support to ensure successful operation
• Coordinate with the process analytics and method development team to align sample submission requests and process workflows
• Support authoring of development reports, tech transfer documents, and other relevant process/regulatory documents for pipeline programs and research collaborations
• Engage in platform development for the evaluation and implementation of novel technologies to improve purification efficiency and product quality

You will need to have:

• BS or MS degree in Biological Engineering, Chemical Engineering, Biochemistry, or related discipline
• 0-3 years of relevant experience in the biotech industry, including internships or co-op experience
• Wet lab experience required
• The duties of this role are 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.

We would prefer for you to have:

• Experience with purification techniques (Clarification, NFF, chromatography, UF/DF)
• Experience authoring technical documents (tech transfer, batch records, IND supporting documents)
• Experience with statistical analysis and design of experiment (DOE) using software tools such as JMP

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.