Sr. Process Engineer III - New Process Introduction & Process Improvement

Employer
Kite Pharma
Location
Frederick, MD
Posted
Jan 26, 2022
Closes
Jan 29, 2022
Ref
334322298
Function
Engineer, IT, QA Engineer
Industry
Engineering
Hours
Full Time
Job DescriptionEveryone 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 Senior Process Engineer III, New Process Introduction and Process Improvement position is a key technical role within the Site 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 also manage 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.Key responsibilities:Manage Technology Transfers, New Technology Implementation and Process Improvements.Work with site functions to ensure technology transfer deliverables are met.Collaborate with above site level functions - PD/GMSAT and manage site based tech transfer deliverables and overall timelines for the project .Participate in Operational Excellence activities within Tier Structure.Lead 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.Work 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 and provide technical expertise to regulatory filings and health authority questions.Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devicesSupport the implementation of automation and IT infrastructure projectsManage the writing and review of technical documentation (protocols & reports for equipment/instrument qualifications, comparability, and cell therapy manufacturing process validation)Basic Qualifications:PhD in Biochemical Engineering, Biotechnology or Life Sciences with 2+ years of biotech experience orMaster's Degree in Biochemical Engineering, Biotechnology or Life Sciences with 8+ years of biotech experience orBachelor's Degree in Biochemical Engineering, Biotechnology or Life Sciences with 10+ years of biotech experience.Preferred Qualifications:Cell therapy experienceExperience in Technology Transfers and New Process IntroductionsDemonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process developmentIn-depth understanding of scientific and engineering principlesStrong written and verbal communication skillsExperience in statistical analysis using JMP or MinitabKnowledge of data management tools and statistical process controlsProcess validation experience and supporting regulatory filings and inspections.Ability to think critically, and demonstrated troubleshooting and problem-solving skillsExcellent interpersonal, verbal and written communication skillsAbility to function efficiently and independently in a changing environmentSelf-motivated and willing to accept temporary responsibilities outside of initial job descriptionDoes this sound like you? If so, please apply today!#LI-ML1#IND123

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