Manufacturing Engineer - II*

Spectraforce Technologies; San Mateo (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Spectraforce Technologies is seeking a Process Engineer II to advance cell therapy process development, design and execute experiments, and support technology transfer within GMP manufacturing environments.

The role requires hands-on lab work, data analysis, protocol drafting, and collaboration with research, development, and manufacturing teams to drive process improvements and regulatory documentation.

Qualifications

• MS/BS/AS in biochemical/chemical/biomedical engineering or related with pharma/manufacturing process development.
• 2+ years (MS) or 4+ years (BS) or 5+ years (AS) of pharma/manufacturing process development.
• Experience with automated cell therapy platforms and aseptic processing.

Responsibilities

• Design and execute cell therapy process development experiments on automated platforms.
• Lead technology transfer and support GMP manufacturing operations.
• Analyze data, draft protocols, SOPs, and batch records.
• Provide training to GMP manufacturing personnel and communicate results to stakeholders.
• Present results to cross-functional teams and leadership.

Skills

Automated platforms

Cell culture techniques

cGMP manufacturing

Design of Experiments

Statistical analysis

Problem solving

Communication

Independent worker

Team collaboration

Flow cytometry knowledge (plus)

mRNA handling knowledge (plus)

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 + 6+ years pharma/manufacturing experience

Tools

JMP

Minitab

Job description

Title: Process Engineer II

Location: On site in Santa Monica, CA (5 days/week)

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

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

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 Kite's 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.

Education Level:

• 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.
• Well-developed computer skills.
• 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