Hiring company: Kite Pharma
Kite is seeking a highly motivated individual with biotechnology experience to work on innovative T cell therapies for cancer treatment. As a Process Engineer I for Manufacturing Sciences and Technology (MSAT), you will provide process science 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 as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements.
Responsibilities (include but are not limited to):
- Perform process support as process development representative for manufacturing site
- Author impact assessments and root cause analysis for major and critical deviations to maintain routine manufacturing operations and determine appropriate CAPA for manufacturing
- Support cross functional teams to perform root-cause investigations and deviation resolution for moderately complex problems
- Support data-based deviation resolution and improvement projects
- Support manufacturing through risk assessments and remediation measures
- Monitor process performance through data-based trending
- Support continuous improvement projects and support initiatives
- Support development studies. Author protocols and reports for process characterization and validation studies
- Participate in evaluation of new technology and process automation for introduction into GMP manufacturing
- Support regulatory inspections and projects for regulatory commitments
- Support technology transfers and new product introductions
- Act as communication channel between global organizations and site manufacturing
Basic Qualifications:
- BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 0-2 years of relevant experience or
- AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 4 years of relevant experience or
- HS Diploma with 5 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent
Preferred Qualifications:
- Knowledge of pharmaceutical manufacturing of biotechnology products and process development
- Working knowledge of scientific and engineering principles
- Experience with cell therapy products is a plus
- Experience with cell culture or aseptic processing
- General knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- Experience with 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 technical writing abilities
- Participate in determining objectives of assignment. Plan schedules and arranges own activities in accomplishing objectives
- 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!
* This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.