Immediate need for a talented
Cell Therapy Process Development Manufacturing Engineer . This is a
06+months contract opportunity with long-term potential and is located in
Los Angeles, CA (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:26-28251
Pay Range: $50 - $51/hour. Traveler benefits as per agency package. (Benefits vary by vendor and assignment.)
Key Responsibilities:- Design and execute cell therapy process development experiments using automated platforms.
- Perform hands-on laboratory work in a cell culture environment.
- Execute aseptic processing activities in an ISO 5 environment.
- Perform cell culture activities including cell passaging, sampling, fluid handling, media formulation, reagent management, and cryopreservation.
- Develop, optimize, and characterize processes supporting autologous T-cell therapies.
- Evaluate new technologies, materials, equipment, and process improvements for implementation into GMP manufacturing.
- Perform process and equipment analysis and trend performance to identify process improvement opportunities.
- Support development of manufacturing equipment, including hardware, software, single-use systems, and user requirements.
- Apply Design of Experiments (DOE) and statistical analysis to process development studies.
- Use tools such as JMP and/or Minitab to analyze experimental data.
- Apply bioprocess engineering principles related to bioreactors, scale-up, scale-out, hydrodynamics, mass transfer, and process monitoring.
- Support technology transfer from process development into clinical and commercial GMP manufacturing.
- Provide technical training to GMP manufacturing personnel.
- Support manufacturing operations and troubleshooting activities as needed.
- Draft and review protocols, SOPs, manufacturing procedures, batch records, technical reports, and summary reports.
- Prepare presentations and communicate experimental results to cross-functional teams, senior leadership, and external collaborators.
- Collaborate with teams across research, process development, engineering, quality, and manufacturing.
Key Requirements and Technology Experience:- MS in Biochemical Engineering, Chemical Engineering, Biomedical Engineering,
- Biotechnology, or related field with 2+ years of relevant pharmaceutical/biotechnology manufacturing and process development experience; or
- BS in a related engineering/biotechnology discipline with 4+ years of relevant experience
- AS in a related discipline with 5+ years of relevant experience; or
- High School Diploma with 6+ years of relevant pharmaceutical/biotechnology manufacturing and process development experience.
- Experience in cell therapy process development or closely related bioprocess development.
- Experience working with automated cell therapy platforms.
- Hands-on cell culture experience.
- Experience with aseptic processing in an ISO 5 environment.
- Practical experience with bioreactors and bioprocess development.
- Experience with Design of Experiments (DOE) and statistical analysis.
- Experience using JMP, Minitab, or similar statistical software.
- Working knowledge of cGMP/GMP manufacturing and pharmaceutical/biotechnology regulatory requirements.
- Understanding of cell biology, including cell populations, differentiation, phenotype markers, and metabolic pathways.
- Knowledge of bioprocessing principles, including scale-up/scale-out, hydrodynamics, mass transfer, and bioreactor design/monitoring.
- Experience with technology transfer and/or GMP manufacturing support.
- Strong troubleshooting, critical-thinking, and problem-solving skills.
- Strong technical writing, communication, and presentation skills.
- Ability to work independently while collaborating effectively in a fast-paced, cross-functional environment.
- Flow cytometry
- mRNA handling or mRNA process development
- Automated or closed cell-processing systems
- Single-use bioprocessing technologies
- Cell therapy manufacturing
- Process characterization
- Regulatory documentation and technical reports
Our client is a leading
Biotechnology Research Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
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