Process Engineer (Cell Therapy)

Cube Hub Inc.; Santa Monica (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

Cube Hub Inc. in Santa Monica, CA is seeking a Process Engineer (Autologous Cell Therapy) to design and execute laboratory studies for cell therapy process development.

The role involves working on autologous design and development within the Life Cycle Management Team, transferring technologies to GMP manufacturing, and delivering technical reports for regulatory filings. The position requires hands-on lab experience, knowledge of cGMP, and the ability to analyze data and present results to

Qualifications

• 2+ years of experience in process development for cell therapy (MS/BS/AS route)
• Experience with automated platforms and aseptic processing in GMP settings

Responsibilities

• Conduct cell therapy process development experiments using automated platforms.
• Design and execute laboratory studies to evaluate new technologies and materials.
• Perform hands-on lab-based activities in a cell culture lab in GMP environment.
• Develop manufacturing equipment for cell therapy products including hardware and disposables.
• Support technology transfer and GMP manufacturing operations as needed.
• Write and review technical documentation and batch records.
• Communicate results to stakeholders and cross-functional teams.

Skills

Automated cell therapy platforms

Cell culture techniques

cGMP manufacturing

DOE / design of experiments

Statistical analysis (JMP/Minitab)

Cross-functional collaboration

Education

MS in Biochemical/ Chemical/ Biomedical Engineering or related

BS in Biochemical/ Chemical/ Biomedical Engineering or related

AS in Biochemical/ Chemical/ Biomedical Engineering or related

High School diploma with 6+ years pharma/biotech exp

Tools

JMP

Minitab

Bioreactors

Job description

Job Title: Process Engineer (Autologous Cell Therapy)

Location: On site in Santa Monica, California, onsite 5 days/wk

Schedule: M-F 9:00-17:00, occasional weekends depending on business needs

Job Duration: 12 months

Contract/CTH: Potential for conversion depending on needs of business at the end of 12 month contract

Job Description

We are seeking a highly motivated and detail-oriented individual with process development experience to work on innovative T cell therapies for cancer treatment.

The Process Engineer I or II will be responsible for designing and executing experiments in the lab, help process development, process characterization, technology transfer activities, support or improve existing technologies, implement innovative solutions in commercial, and clinical manufacturing to advance client product portfolio.

Additional responsibilities include analyzing and presenting experimental results, drafting / reviewing protocols, production procedures, and technical reports including documentation for regulatory filings.

Process Engineer I or II will work on Autologous Process Design and Development within the Life Cycle Management Team.

Key responsibilities:

• Conduct cell therapy process development experiments using automated platforms.
• Design and execute laboratory studies that support the evaluation, development and implementation of new technologies and materials.
• Perform hands-on lab-based activities in a cell culture lab, including conception of study designs and analysis of data
• Perform process or equipment analysis and trend process or equipment performance.
• Develop manufacturing equipment for cell therapy products including hardware, software, and single-use disposable design elements and user-requirements.
• Participate in the evaluation of new technologies and materials for introduction into GMP manufacturing
• Provide process training to GMP manufacturing personnel.
• Support technology transfer and GMP manufacturing operations as needed.
• Perform statistical analysis using software such as JMP, Minitab and perform design of experiments (DOEs) as appropriate.
• Write and review technical documentation, technical SOPs, draft manufacturing batch records, technical reports and summary reports.
• Create and present slides with supporting data to communicate results to stakeholders, cross-functional project teams, senior leadership or external collaborators.
• Perform other duties as assigned.

MS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or related discipline with pharmaceutical / biotechnology manufacturing & process development with 2+ year of experience or

BS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 4+ years of experience or

AS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 5+ years of experience or

High School diploma with 6+ years of pharmaceutical / biotechnology manufacturing & process development experience.

Experience

Working experience on automated cell therapy platforms

Established cell culture lab techniques and aseptic processing in an ISO 5 environment such as cell passaging, sampling, fluid handling, media formulation, managing reagents, and cryopreservation.

Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.

Practical demonstration of hands-on process development including use of bioreactors and use of statistical design of experiments is required.

Mastery of scientific and engineering principles related to bioprocessing including scale-up / scale-out approaches, hydrodynamics, mass transfer, and bioreactor design and monitoring fundamentals.

Fundamental understanding of cell biology principles, sub-population types, differentiation, phenotype markers and metabolic pathways.

Knowledge of material science and material compatibility for cell culture applications

Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development.

Ability to think critically, troubleshoot, and problem solve in a timely manner.

Excellent interpersonal, verbal and written communication skills are required.

Ability to function efficiently and independently in a changing environment.

Self-motivated, strong sense of responsibility, and willing to accept temporary responsibilities outside of initial job description.

High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.

Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

Ability to work and collaborate in a fast pace dynamic cross-functional team setting across research, development, and manufacturing departments.

Flow cytometry knowledge is a plus

mRNA handling and process knowledge is a plus.