Senior Scientist, Process Development

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.

Position Summary

The Senior Scientist, Process Development leads process development activities and ensuring the application of well-designed unit operations for use in the clinical manufacture of cell therapy products. You will work with colleagues in Analytical Development, Research, Manufacturing, Quality Control/Assurance, Regulatory, and other areas. This role is based in Santa Monica, CA, and reports to the Senior Director, Process Development.

Responsibilities

• Guide autologous platform and process development efforts focused on T-cell derived cell therapies.
• Support technology transfer of autologous T-cell derived cell therapies processes into the development and clinical manufacturing environment.
• Directly support implementation of automated end-to-end manufacturing processes, working directly with equipment vendors and internal resources to ensure successful outcomes.
• Collaborate with and participate in teams to facilitate IND-enabling, clinical Phase I/II-promoting activities.
• Perform data analysis, provide interpretation, and integrate results into the context of a project.
• Independently design strategies for implementation of scalable upstream and downstream manufacturing processes of engineered T cells.
• Collaborate within the project team to interpret study results and contribute to technical discussions for subsequent study design.
• Prepare experimental proposals, technical reports, SOPs and manufacturing batch records.
• Communicate program progress and issues to management.
• Work collaboratively within PD group and with other groups to meet Technical Operation organization goals.
• Other responsibilities as assigned.
• Oversee associates in execution of development activities.
• Potentially oversee laboratory, equipment, and facilities.
• Mentor staff in career development and managing development plans

Education and Experience

• PhD in Immunology, Biological Sciences, Biomedical Engineering, or related field with 3+ years of experience (academic experience post-graduate also considered) OR MS in with at least 6 years of industry experience (relevant academic experience also considered) OR a BS with at least 8 years of industry experience is required.
• Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required.
• Experience in autologous T cell therapy manufacturing is required.
• Prior hands-on experience with automation equipment and end-to-end systems is required; expertise in their operations in both process development and manufacturing environments for cell therapies is advantageous.
• Knowledge of cGMP manufacturing and regulations and practical experience in GMP operations.
• Knowledge of statistical analysis for process development.
• Design and complete experiments.

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.

The annual base salary for this position ranges from $119,110 to $145,578. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and 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.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.

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