Cell Therapy Process Development Manufacturing Engineer

Pyramid Consulting, Inc; Los Angeles (CA); On-site; USD 143,270,000 - 146,136,000; Full time

Job summary

Pyramid Consulting, Inc. is actively seeking a Cell Therapy Process Development Manufacturing Engineer for a 6+ month onsite contract in Los Angeles, CA.

The role focuses on hands-on cell culture and aseptic processing within ISO 5 environments, employing automated platforms and DOE-driven process optimization. The engineer will contribute to tech transfer and GMP manufacturing support, collaborating with cross-functional teams.

Qualifications

• 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.

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.
• Develop, optimize, and characterize processes supporting autologous T-cell therapies.
• Evaluate new technologies, materials, equipment, and process improvements for GMP manufacturing.
• Apply Design of Experiments (DOE) and statistical analysis to process development studies.

Skills

Cell therapy

Process development

Automated platforms

DOE/Statistics

JMP/Minitab

cGMP/GMP

Flow cytometry

MRNA handling

Bioreactors/Scale-up

Education

MS in Biochemical/Chemical/Biomedical Engineering

BS in related engineering/biotech with 4+ years

AS with 5+ years

HS with 6+ years

Tools

JMP

Minitab

Job description

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).

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.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.