Process Engineer II- MSAT

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

Kite is seeking a highly motivated individual with cell therapy or biologics manufacturing experience to provide manufacturing support for a new commercial Cell Therapy manufacturing facility in Frederick, MD. The Process Engineer II position is a key technical role within the Manufacturing Science and Technology (MSAT) organization.  This role will provide process engineering support for the validation and commercial manufacturing of cell therapy products. Working

cross functionally with quality, operations, process development, and facility/engineering functions, the role is expected to provide technical input for deviation investigations, new technology implementation, technology transfers, process validation, and regulatory filings.

Key responsibilities:

* Serve as a subject matter expert to lead product impact assessments for deviations.

* Monitor and analyze manufacturing data to provide support for investigations, continued process verification, and process improvements.

* Participate in process FMEAs to understand process and product risks to support tech transfer and product lifecycle management.

* Participate and report to a cross-functional team to advance production activities and site capabilities.

* Identify continuous improvement opportunities and support implementation in Manufacturing through Operational Excellence

* Ensure a systematic DMAIC based approach is utilized for process/product related investigations to identify root cause and provide impact assessment to support routine manufacturing operations and determine process improvements for manufacturing.

* Support technology transfers for launch and commercialization of cell therapy products.

* Provide technical expertise to support regulatory filings and health authority questions.

* Effectively summarize and communicate manufacturing process performance internally and externally.

* Support the implementation of automation and IT infrastructure projects.

* Design and execute laboratory studies to support process/product understanding and continuous improvement projects

* Author technical documents (protocols & reports for laboratory studies, comparability, and process validation)

Basic Qualifications:

* Master's Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or Life Sciences with 2+ years of industry experience.

* Bachelor's Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or Life Sciences with 4+ years of industry experience.

Preferred Qualifications:

* Cell therapy experience

* Demonstrated knowledge of biopharmaceutical manufacturing, aseptic processing, cell therapy, and process development

* Practical expertise with cGMP manufacturing and regulatory requirements

* In-depth understanding of scientific and engineering principles

* Experience in statistical analysis using JMP or Minitab

* Knowledge of data management tools and statistical process controls

* Process validation experience including support for regulatory filings and inspections

* Ability to think critically, with demonstrated troubleshooting and problem-solving skills

* Excellent interpersonal, verbal and written communication skills

* Ability to function efficiently and independently in a fast-paced environment

* Self-motivated and willing to accept temporary responsibilities outside of initial job description

The salary range for this position is: $99,705.00 - $. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid,…