ACCOUNTABILITIES

• Lead the design and execution of laboratory experiments to develop and optimize upstream processes for AAV production, including cell culture, transfection, production, and harvest/lysis.
• Troubleshoot process-related challenges and implement corrective actions to optimize production yields and maintain product quality.
• Analyze and interpret experimental data, utilizing statistical tools to drive scientific decision-making and process improvements.
• Develop tools and databases to interpret large datasets to guide process development decisions, troubleshoot issues, and inform process improvements.
• Collaborate with cross-functional teams including Downstream, Process Analytics, and Research.
• Oversee and execute tech transfer activities for AAV production processes to cGMP manufacturing sites.
• Work closely with cross-functional CMC teams to ensure alignment on project goals and timelines.
• Provide technical input and support for drug substance (DS) development on Genomic Medicines CMC teams.
• Prepare and contribute to key documentation for regulatory submissions (e.g., INDs, BLAs).
• Document experiments and results clearly and accurately in production files and electronic laboratory notebooks.
• Summarize and present results to the broader team.
• Lead the drafting of process development reports, process descriptions, and tech transfer documents.
• Manage and maintain lab equipment and supplies, ensuring a safe and efficient work environment.
• Mentor junior engineers and scientists, sharing knowledge and best practices in AAV production and upstream bioprocessing.
• Develop and implement new platform technologies to enhance AAV production processes, evaluating innovative methods and tools that improve yield, quality, and efficiency.

ESSENTIAL SKILLS/EXPERIENCE

• BS or MS degree in Biomedical Engineering, Chemical Engineering, Biotechnology, or a related field
• Minimum of 8+ years of relevant experience in the biotech industry
• Hands-on experience with mammalian cell culture, aseptic technique, and bioreactor operation
• Experience with AAV or other viral vectors and transient transfection
• High level of proficiency in MS Office software
• Proficient in data analysis tools and statistical software applicable to process development (e.g., DOE, JMP)
• The duties of this role are generally 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; 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

• Familiarity with regulatory requirements (FDA, EMA) specific to AAV bioprocess and gene therapy products
• Experience on CMC teams
• Proficiency in data visualization tools (e.g., Prism)
• Proficiency in project planning tools (e.g., Smartsheet)
• Experience working with CDMOs
  At AstraZeneca, we thrive in an environment where change is the only constant. We embrace uncertainty and ambiguity, taking calculated risks to deliver new medicines to patients. Our supportive yet challenging approach fosters continuous improvement and innovation. Here, every setback is an opportunity to learn, every critique pushes us towards groundbreaking solutions. We value dedication, resilience, and the courage to make bold decisions that can change lives.
  Join us in making a profound impact on society and patients worldwide. Apply today!
  The annual base salary for this position ranges from $110,000 to $166,000. 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.

Are you ready to play a pivotal role in the development of adeno-associated virus (AAV) production processes for gene therapy applications? As an Engineer IV in the Upstream Process Development team, you will collaborate with a multidisciplinary team to design, optimize, scale up, and tech transfer upstream processes involved in the production of viral vectors. This is your chance to make a significant impact in the field of gene therapy!