Associate Scientist, Analytical Tech Transfer Lead

职位描述

Associate Scientist, Analytical Development (27)

We are seeking a highly motivated individual with a background in analytical method transfer and lifecycle management experience to join us as Associate Scientist, Analytical Operations, at our Santa Monica, California location. The individual will work within cross functional groups in analytical development, process development and quality control to facilitate interdepartmental and external analytical method transfers and life cycle management. With appropriate guidance, this individual will also lead building an extensive method monitoring program and implementation of new technologies.

Responsibilities include (but are not limited to):

• Manage and lead analytical technology transfer for new programs and external partners

• Facilitate clinical and commercial method transfers from external partners/research to AD and from AD to customer facilities like QC by authoring transfer documentation and training plans, and providing review of validation protocols and reports to meet filing standards

• Maintain project timelines and dashboards for visibility to product team

• Develop cross-functional method monitoring methodologies and perform statistical analysis as part of life cycle direction to promote critical thinker changes to methods

• Ensure standard operating procedures, analytical test methods, analytical sampling plans, and monitoring, trending and improvement processes for analytical methods to meet the highest industry standard

• Coordinate activities to support investigational troubleshooting of methods in Clinical and Commercial Quality Control during and post technology transfer

• Engage at cross-functional AD/QC meetings including Method Monitoring Working Teams and Software Alignment teams to ensure consistent analytical testing across the Kite network

• Lead gap and risk assessments to enable LCM of analytical methods to meet milestones for continuous improvement of commercial programs

Basic Qualifications:

• Master’s Degree and 3+ years of related industry/academic experience OR

• Bachelor’s Degree and 5+ years of related industry/academic experience OR

• High School Degree and 9+ years of related industry experience

Preferred Qualifications:

• In-depth experience with CMC technology transfer and cGMP requirements and testing in Clinical and Commercial Quality Control; experience with cell therapies is a plus

• Project management experience and proficient in project management resources such as Smartsheets, Spotfire, Clarity.

• Knowledge of biostatistics and method monitoring/trending analysis on JMP/Prism or other analysis software

• Ability to lead a cross-functional, diverse, experienced technical staff

• Ability to think critically and demonstrate troubleshooting and problem-solving skills, and work with and lead others

• Basic knowledge in analytical techniques such as Flow cytometry, qPCR, ddPCR, ELISA and compendial methods techniques

• Proficient in MS Word, Excel, Power Point and other applications

• Ability to function efficiently and independently in a changing environment

• Comfortable in a exciting small company environment with minimal direction and able to adjust workload based upon changing priorities

• Self-motivated, detail-oriented, excellent interpersonal and writing skills, and willing to accept temporary responsibilities outside of initial job description

• Excellent interpersonal, verbal and written communication skills