Senior Process Engineer

Position Summary

The Senior Process Engineer, Process Development is a laboratory-based role responsible for support development of a clinical manufacturing process of engineered T cells with patient-derived neo-antigen specific TCRs. Additionally, this role evaluates technology and process improvements and plays a key role in process understanding and process characterization. Additionally, the process engineer will be involved in manufacturing support and technology transfer to ensure successful implementation in a cGMP environment. This role is based in Santa Monica, CA and reports to the Director, MSAT.

Responsibilities

• Design, execution, analysis, and documentation of early and late stage process development studies to develop, optimize, characterize and transfer cGMP manufacturing processes. Involves cell culture of T cells in multiple formats including flasks, bags, and bioreactors.
• Collaborates within the team to interpret study results and contribute to technical discussions cross functionally for subsequent study design and decision making.
• Contributes to manufacturing support efforts; including batch record and SOP development, real-time troubleshooting, investigation and impact assessment for deviations, change control management, process monitoring and data analysis, and risk assessments.
• Serves as a project/program manager with independent discretion.
• Perform other duties and special projects as assigned.

Required Skills

• 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
• Strong verbal and written communication skills, including technical writing.

Education and Experience

• 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.

The annual base salary for this position ranges from $126,000 to $157,000. 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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