Senior Scientist, Process Development

The Senior Scientist Process Development leads process development activities and ensures the application of welldesigned 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 Associate Director Process Development.

What you will do:

• Guide autologous platform and process development efforts focused on Tcellderived cell therapies.
• Support technology transfer of autologous Tcell derived cell therapy processes into the development and clinical manufacturing environment.
• Directly support the implementation of automated endtoend manufacturing processes working with equipment vendors and internal resources to ensure successful outcomes.
• Collaborate with and participate in teams to facilitate INDenabling clinical Phase I/IIpromoting 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 the execution of development activities.
• Potentially oversee laboratory equipment and facilities.
• Mentor staff in career development and managing development plans

Minimum Qualifications:

• PhD in Immunology Biological Sciences Biomedical Engineering or related field with a minimum of 3 years of experience (academic experience postgraduate also considered) OR MS with a minimum of 6 years of industry experience (relevant academic experience also considered) OR a BS with a minimum of 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 Tcell therapy manufacturing is required.
• Prior handson experience with automation equipment and endtoend 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 lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 $108474 to $162710.However base pay offered may vary depending on multiple individualized factors including market location jobrelated knowledge skills and experience. In addition our positions offer a shortterm incentive bonus opportunity; eligibility to participate in our equitybased longterm incentive program (salaried roles) or to receive a retirement contribution (hourly 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 atwill 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.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industryleading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.

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