Aptask Global Workforce (AGW) is seeking a Process Engineer II for an Onsite position with a Global Biotechnology Company located in Santa Monica, CA. This is a 12+ month contract opportunity. This role is for a highly motivated and detail-oriented individual with process development experience to work on innovative T cell therapies for cancer treatment. The Process Engineer will be responsible for designing and executing experiments in the lab, assisting with process development, process characterization, and technology transfer activities. The successful candidate will work to support or improve existing technologies and implement innovative solutions in commercial and clinical manufacturing.
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
Requirements: - MS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or related discipline with 2+ years of experience OR BS Degree with 4+ years of experience OR AS Degree with 5+ years of experience OR High School diploma with 6+ years of experience in pharmaceutical/biotechnology manufacturing & process development
- Working experience on automated cell therapy platforms
- Established cell culture lab techniques and aseptic processing in an ISO 5 environment
- Practical knowledge of cGMP manufacturing and regulatory regulations for pharmaceuticals and devices
- Practical demonstration of hands-on process development including use of bioreactors and use of statistical design of experiments
- Mastery of scientific and engineering principles related to bioprocessing
- Fundamental understanding of cell biology principles
- 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
- Ability to work and collaborate in a fast-paced dynamic cross-functional team setting
Desired skills: - Flow cytometry knowledge is a plus
- mRNA handling and process knowledge is a plus
Pay range: up to $51.25 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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