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Manufacturing Engineer - II

•#26-27017

$50.00-$51.25 per hour

Santa Monica, CA

Onsite Job Description

Internal Title:

Process Engineer II

Bill Rate:

•

Location:

1800 Stewart St Santa Monica, fully on site

Schedule:

M-F 8:00-17:00

Contract/CTH:

Potential for extension or conversion depending on needs of business

Kite Pharma 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 Kite's 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 Kite's 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

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."