Process Engineer III - MSATUnited States - Maryland - FrederickProcess/Product Development & OperationsRegular
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 cell therapy or biologics manufacturing experience to work on commercializing a Greenfield Cell Therapy manufacturing facility in Frederick Md. The Process Engineer III, New Process Introduction and Process Improvement position is a key technical role within the Manufacturing Science and Technology (MSAT) organization. This role will provide process engineering and Project Management support to the introduction of new processes into the site and transfer of technology from the site. The role will assist in managing process related improvements. Working cross functionally with quality, operations, facility and engineering and supply chain functions, the role is expected to manage technology transfers for the site, technology implementation, process validation and regulatory filings.
- Support Technology Transfers, New Technology Implementation and Process Improvements.
- Work with site functions to ensure technology transfer deliverables are met.
- Manage site based tech transfer deliverables and overall timelines for the project.
- Participate in Operational Excellence activities within Tier Structure.
- Support continuous improvement projects supporting the commercial manufacturing site.
- Support Process Improvement Initiatives and work with cross functional teams to implement in Improvements in GMP manufacturing.
- Assist with Process Development and site MSAT process support and lab groups to test efficiency projects and show feasibility.
- Work with QC, Operations, supply chain and Facilities and Engineering to ensure Technology Transfer Deliverables and timelines are met.
- Review regulatory filings as applicable to projects
- Practical expertise with cGMP manufacturing and some regulatory requirements for pharmaceuticals and devices
- Support the implementation of automation and IT infrastructure projects
- Review of technical documentation (protocols & reports for equipment/instrument qualifications, comparability, and cell therapy manufacturing process validation)
- MA/MS Degree in Biochemical Engineering, Biotechnology or Life Sciences with 3+ years of biotech experience or
- BA/BS Degree in Biochemical Engineering, Biotechnology or Life Sciences with 5+ years of biotech experience.
- Cell therapy experience
- Experience in Technology Transfers
- Project Management experience
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
- In-depth understanding of scientific and engineering principles
- Strong written and verbal communication skills
- Experience in statistical analysis using JMP or Minitab
- Knowledge of data management tools and statistical process controls
- Process validation experience and supporting regulatory filings and inspections.
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
Does this sound like you? If so, please apply today!