Introduction to role
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.
Accountabilities
- Process Development: Aid in the design, development, and optimization 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.
Essential Skills/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.
Desirable Skills/Experience
- Hands-on experience in cell and gene therapy, specifically in T cells is highly desirable.
- Experience with Flow Cytometry is highly desirable.
The annual base salary for this position ranges from $97,175-$145,762. 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. 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.
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 ambitious world.
At AstraZeneca, we are at the forefront of pioneering new approaches and processes across our sites. We empower our teams to foster a Lean mindset and sustainable practices, ensuring every change we make delivers better outcomes for our patients. Our environment is one where every day brings new challenges, encouraging adaptability and collaboration. We value diverse expertise and champion ideas from all team members, creating a supportive atmosphere where everyone has a voice.
Ready to make a difference? Apply now to join our team!
Date Posted
16-Dec-2024Closing Date
30-Jan-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.