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!
Date Posted
29-Aug-2024Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.