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Senior Process Engineer, Process Development

2 months ago

Santa Monica, United States AstraZeneca Full time
Job Description

Join our team as a Senior Process Engineer in Process Development, where you'll be responsible for supporting the development of a clinical manufacturing process of engineered T cells with patient-derived neo-antigen specific TCRs. Additionally, this role evaluates process and technology improvements, is critical to process understanding and process characterization, and is involved in manufacturing support and technology transfer to ensure successful implementation in a cGMP environment. This laboratory-based role works with the Senior Scientist, Process Development in Santa Monica, CA. If you're looking to work with curious minds in an inclusive culture, this is the place for you

Accountabilities:

As a Senior Process Engineer, serving as a project manager with independent discretion you will 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 cross functionally 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.

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.
  • 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.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Ready to join our team and make a difference? Apply now

Date Posted

01-May-2024

Closing 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.