Principal Engineer – MSAT Data Science

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

We are looking for an experienced Principal Engineer of MSAT to join our dynamic team. You will help enable establishment of manufacturing repositories, automating inputting of data and contributing to important CMC strategies and submission. You will lead teams and collaborate with all partners to ensure seamless technology transfer processes.

This position is based in Santa Monica, CA and reports to the Director MSAT.

We offer the opportunity to join a dynamic biotech startup. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value proactive team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

Responsibilities

• Project Owner for Manufacturing Global Data Management system at the Santa Monica site: implement and processing the data entry set up and process data analysis.
• Lead project team meetings at established frequencies and is accountable for successful project execution.
• Collaborate with important partners to gather user requirements for process data track and trending.
• Set up web-based data entry templates to help appropriate analysis and ensure entry and verification/integrity of process data.
• Help maintain high quality data collection systems and continuous improvement.
• Perform advanced statistical analysis to support deviations and investigations and use statistical process controls.
• Guide data mining of large database to go from information to knowledge.
• Collaborate with IT and other departments to automate systems for data entry and import.
• Author, reviews and approves deviations, investigations technical report, MRB and campaigns summary reports
• Establish criteria of assays equivalence and process comparability
• Support Process Development team with DOE and DOE analysis
• Support CMC commercial readiness activities in preparation of PPQ activities (identification of NOR and PAR)
• Develop documentation, including standard operating procedures, batch records, and technology transfer protocols. Author technical documentation.
• Develop relationships with all partners to meet requirements.

Education and Experience

• Bachelors' Degree or equivalent in an engineering discipline (biomedical, chemical, biochemical), or a life science equivalent with eight (8) plus years of experience manufacturing environment. A Master's degree in a related field with six (6) years .
• Eight (8) years working experience in GMP field
• Statistical skills applied to bioprocesses
• Excellent program management
• Prior experience applying advanced statistical analysis to manufacturing databases.
• Comfortable with creating datasets.
• Experience with CMC product lifecycle and GMP requirements.
• Knowledge of statistics tools (e.g. ANOVA, T-tests, Regression, Control Charts) and Deep Learning Algorithms
• Understanding of cell therapy unit operations and GMP requirements
• Distill complex analyses into easy to understand presentations.
• Knowledge of JMP, C+ or Python or other programming languages
• Find creative solutions to issues and obstacles.

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 $160,923 to $181,039. 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.

DE&I Statement

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 industry-leading 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 non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.