Process Engineer II

Job Title: Process Engineer II
Location: Santa Monica, CA 90404
Duration: 12 Months (Possibility of extension depending upon business requirements and performance)
Schedule: M-F 8:00-17:00

Job Description:

• The client is seeking a highly motivated individual to join the Process Design team to develop innovative manufacturing processes for T cell therapies.
• As a Process Engineer II in Process Design, you will provide hands-on lab support for studies supporting new INDs, technology transfers, process validations, and GMP manufacturing for company engineered T cell therapy products.
• Additionally, you will draft and review protocols, production procedures, and process design reports.
• You will work with a highly motivated team to design and scale cell therapy processes to advance company product portfolio.

Key responsibilities:

• Hands-on lab work and collaboration on process design studies to support process development, optimization, characterization, and essential process improvements
• Perform process training for GMP clinical production
• Participate in a cross-functional development team to advance CMC activities
• Perform process analysis and trend process performance
• Develop manufacturing processes for cell therapy products
• Design and execute process development studies to develop a thorough understanding of operating and performance parameters
• Perform statistical analysis, including design of experiments (DOEs) as appropriate
• Write and review technical documentation from writing technical SOPs, study plans, draft manufacturing batch records, technical reports, and summary reports
• Create slides and supporting data to communicate results to senior leadership
• Other collaboration and cross-functional activities as assigned

Basic Qualifications:

• MS Degree in Biochemical Engineering, Chemical Engineering, or related discipline with 0 years of pharmaceutical manufacturing, technology transfer & process development experience required
• BS Degree in Biochemical Engineering, Chemical Engineering, or related discipline with 2 years of pharmaceutical manufacturing, technology transfer & process development experience required?

Required Qualifications:

• Demonstrated cell culture and aseptic technique experience is required, including basic cell culture, preparation of media, cell counting, managing reagents and cryopreservation
• Ability to think critically, and demonstrated troubleshooting and problem-solving skills
• Excellent interpersonal, verbal, and written communication skills are required
• 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 cross-functional teams, i.e., Research, Translational medicine, Process development, Manufacturing, MSAT in a fast pace, the dynamic team setting

Preferred Qualifications:

• Basic knowledge of Immunology and T-cell biology
• Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
• Practical demonstration of hands-on process development, including using the statistical design of experiments
• Experience with bioreactors
• Understands and employs principles and concepts of Lean Six Sigma or design of experiments to improve process capability is a plus
• Experience in statistical analysis using JMP or Minitab
• Knowledge of data management tools and statistical process controls