Engineer II, Downstream Development, Viral Vector Product Development

Job Title: Engineer II, Downstream Development, Viral Vector Product Development

Introduction to role

Are you ready to explore and innovate in a dynamic environment? As an Engineer II in Downstream Development for Viral Vector Product Development, you will design and execute experiments focused on downstream AAV (Adeno-Associated Virus) manufacturing processes. You will play a crucial role in the purification team by generating, summarizing, and presenting experimental data to recommend process operating conditions. Your goal will be to develop robust and scalable manufacturing processes. Additionally, you will draft documentation and provide expertise to support scale-up and tech transfer to clinical/commercial manufacturing facilities and regulatory filings.

Accountabilities

• Support the downstream development of AAV manufacturing processes to optimize viral vector purification steps (chromatography, filtration, UF/DF)
• Independently perform OFAT and DoE-directed experiments to identify key and critical process parameters 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, providing person-in-plant (PIP) support when necessary
• 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

Essential Skills/Experience

• BS or MS degree in Biological Engineering, Chemical Engineering, Biochemistry, or related discipline with 3+ years (BS) or 0 years (MS) experience in the biotech industry, including internships or co-op experience
• Wet lab experience required
• The duties of this role are conducted in a lab environment. Employees must be able, with or without accommodation, to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with 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.

Desirable Skills/Experience

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

At AstraZeneca, we are committed to making a difference by following the science to explore and innovate. We work towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Our dynamic environment encourages creativity and bold decision-making. We celebrate successes and learn from failures as we push the boundaries of science to deliver life-changing medicines. Join us to be part of a team that leverages diverse global knowledge to create the greatest impact on disease.

Ready to make a difference? Apply now!

The annual base salary for this position ranges from $87,000 to $130,000. However, 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) or to receive a retirement contribution (hourly 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.