Senior Process Engineer

Position Summary

The Senior Process Engineer, Process Development is a laboratory-based role responsible for supporting the development of clinical manufacturing processes for engineered T cell products. This position involves collaborating multi-functionally to ensure the development and implementation of these products into a cGMP environment, while also working to maintain and further optimize production processes currently in the clinical setting. This role is based in Santa Monica, CA, and reports to the Associate Director, Process Development.

Responsibilities

• Process Development: Aid in the design, development, optimization, and characterization of cell therapy manufacturing processes by leading projects and workstreams.
• Perform cell culture of T cells in multiple formats including flasks, bags, and bioreactors.
• Define appropriate studies regarding process investigations as required to support manufacturing activities and regulatory filings.
• Prepare and review experimental proposals, technical reports, SOPs, and manufacturing batch records.
• Collaborate within the project team to interpret study results and contribute to technical discussions for subsequent study design.
• Aid in the identification of new bioprocessing technologies and their implementation in cGMP manufacturing processes.
• Perform other duties and special projects as assigned.

Education and Experience

• Knowledge of cGMP manufacturing and regulations and practical experience in GMP
• 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 primary human cell culture. Experience with T cells highly preferred.
• BS degree in Biochemical Engineering, Biomedical Engineering, Biotechnology or related field with 6 years OR MS degree with 4 years OR PhD with 1-year relevant industry experience.
• Experience in technical development of cell and gene therapy or biologics in early and late-stage development.
• Hands-on experience in cell and gene therapy, specifically in T cells is highly desirable.
• Experience with Flow Cytometry is highly desirable.

#LI-onsite #CellTherapy

When we put unexpected teams in the same room, we unleash 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 daring world.

At AstraZeneca, we follow the science and pioneer new frontiers. Our team is dedicated to Oncology with a vision to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. We fuse cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we aim to deliver six new molecular entities by 2025. Our environment is built on courage, curiosity, and collaboration, empowering you to lead at every level and take smart risks that drive patient outcomes.

Ready to make a difference? Apply now and join us on this exciting journey!

The annual base pay (or hourly rate of compensation) for this position ranges from $97,175-$145,762. 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.

Date Posted

14-Jan-2025

Closing Date

09-Feb-2025Our 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.