
Process Engineer II - Lab Support
United States - California - El SegundoProcess/Product Development & OperationsRegularJob Description
Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?
Kite is seeking a highly motivated individual with biotechnology experience to work on innovative T cell therapies for cancer treatment. As a Process Engineer II for Manufacturing Sciences and Technology (MSAT), you will provide lab support for commercial GMP manufacturing, technology transfers, development studies, validation, and continuous improvement projects for Kite’s engineered T cell therapy products. Additionally, you will author product impact assessments, root-cause analysis reports, sampling plans, technical reports, and provide technical assessments, rationales and approval for engineering/ process changes. MSAT is currently building out a lab and this position will eventually transition into lab scientist position that will support deviation investigation and reduction.
Responsibilities (include but are not limited to):
- Perform lab support as the process development representative for manufacturing site
- Author process and product impact assessments
- Support cross functional teams to perform root-cause investigations and deviation resolution for moderately complex problems
- Monitor process performance through data-based trending
- Data based deviation resolution and improvement projects
- Support manufacturing through risk assessments and remediation measures
- Collaborating with technical and operational stakeholders, write and review SOPs, batch records, and other operational related documents as needed
- Lead continuous improvement projects and support initiatives
- Support development studies. Author protocols and reports for process efficiency studies
- Participate in evaluation of new technology and process automation for introduction into GMP manufacturing
- Support regulatory inspections and projects for regulatory commitments
- Act as communication channel between global organizations and site manufacturing
- Support building of new lab
- Once the lab is built, the roles will expand to
- Perform assay or tests for investigation of process/equipment/material issues.
- Design and author experimental studies
- Conducts technical and scientific training
Requirements:
- BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 4+ years of relevant experience or
- MS in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 2+ years of relevant experience or
- HS Diploma with 6 + years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent
Preferred Qualifications:
- Basic knowledge in analytical techniques (eg. Flow)
- Demonstrates ability in executing assays or test and interpreting experimental outcomes
- Have an understanding of process development, validation, and Lifecycle management to support comparability studies, process validation, and licensure changes
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture, and process development
- Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- Experience with leading investigations, writing deviation reports, change controls, and corrective actions
- Ability to share complex principles of knowledge to others (team member, stakeholder, external, or inspection) along with strong technical writing abilities
- Experience working with or leading cross functional teams to obtain project deliverables
- Working knowledge of scientific and engineering principles
- Knowledge of data management tools and statistical process controls
- Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus
Does this sound like you? If so, please apply today!
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