Job description
Senior Process Engineer
Santa Monica, CA
Our client is a global, clinical stage biotechnology company using tumor mutation profiles to engineer individualized T cell therapies.
Position Summary
The Senior Process Engineer, Process Developmentis a laboratory-based role responsible for support development of a clinical manufacturing process of engineered T cells with patient-derived neo-antigen specific TCRs. This individual will evaluate technology and process improvements, and play 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 Senior Scientist, Process Development.
Essential Functions and 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.
Supervisory Responsibilities
No supervisory responsibilities.
Required Skills/Abilities
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 a minimum of -six (6) years OR MS degree with a minimum of four (4) years OR PhD with a minimum of one (1) year of 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.
Please note, the final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.