Senior Engineer, Cell Therapy Process Development at AstraZeneca in Gaithersburg, Maryland

Job Description:

Senior Engineer, Cell Therapy Process Development



Are you ready to push the boundaries of science and change the practice of medicine? We are looking for a Senior Process Engineer to join our Cell Therapy Process Development team. In this role, you'll be instrumental in supporting the development of a clinical manufacturing process of autologous CAR-T products. This is an opportunity to work with curious minds in an inclusive culture, where you'll be evaluating process and technology improvements, contributing to process understanding and characterization, and providing manufacturing support and technology transfer in a cGMP environment.



Accountabilities:



As a Senior Process Engineer, you will independently design, implement, analyze, and document early and late-stage process development studies. You will collaborate within the team to interpret study results and contribute to technical discussions for subsequent study design and decision making. You will also contribute to manufacturing support efforts, including batch record and SOP development, real-time troubleshooting, investigation, and impact assessment of deviations, change control management, process monitoring and data analysis, and risk assessments. Additionally, you will author and contribute to development reports, scientific publications, patents, and regulatory filings in different countries and regions.



Essential Skills/Experience:

• BS degree in Biochemical Engineering, Biomedical Engineering, Biotechnology, or related field with a minimum of six (6) years OR MS degree with a minimum of four (4) years OR PhD with a minimum of one (1) year of relevant proven experience.
• Knowledge of cGMP manufacturing and regulations and practical experience in GMP operations.
• Knowledge of QbD, DOE and statistical analysis tools (e.g., JMP, Minitab).
• Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning.
• Highly organized, able to work in a fast-moving environment and prioritize work to achieve goals.
• Strong verbal and written communication skills, including technical writing.
• Experience in technical development of cell and gene therapy or biologics in early and late-stage development setting.
• Hands-on experience in cell and gene therapy, specifically in T cells is highly desirable.
• Comprehensive knowledge of regulatory requirements and experience with regulating filing at different clinical stages in US, UK/EU and other countries and regions.



Desirable Skills/Experience:

• Experience with CAR-T cell therapy
• Familiarity with oncology clinical trials
• Experience with process development for cell therapies


At AstraZeneca's Oncology R&D department, we are united in our vision to eliminate cancer as a cause of death. We are pioneers in our field, making bold moves that transform the way cancer is treated and truly improve patient outcomes. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs. We believe in growing together and providing a place where everyone can have a voice. We are ambitious, collaborative, resilient, diligent, committed to our science-driven approach, with a sharp focus on outcomes. We foster a mindset of courage, where everyone is empowered to step up, innovate and work at pace.



Ready to join us on this mission? Apply now!



The annual base pay for this position ranges from $ 107,244.80 - $160,867.20. 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.


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.