Manufacturing Engineer - II*

Job Title: Process Engineer/Manufacturing Engineer 
Location: Santa Monica, CA
Duration: 12 Months
Schedule: M-F 8:00-17:00

Job Description:
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 CClient 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