What you will do:

• Lead and supervise a cell based assay-focus team including scientists and research associates
• Focus on analytical method development, assay qualification and validation, analytical strategies for multiple cell therapy programs
• Serve as SME for cell-based assays and actively contribute to establish product potency and safety assays for characterization of CAR T manufacturing process and drug products
• Provide analytical support for CMC and product development team for clinical-scale IND-enabling manufacturing operations, including assay qualification and assist in tech transfer in support of GMP lot release and characterization
• Establish tracking and trending analysis of analytical attributes for process development runs and GMP production runs, including evaluation of critical reagents and lot to lot variability, in order to improve analytical assay performance and support process validation for Phase II clinical trial and BLA
• Good understanding of cGMP environment, and Quality by Design (QBD) principles for process and assay development, qualification and validation preferred
• Collaborate closely with other functions to enable effective and successful project development; actively engage in cross-functional collaboration with peers to overcome challenges
• Organize, communicate, and present complex data sets to key stakeholders and senior management
• Draft SOP, technical reports and CMC sections for regulatory filing

What you will bring:

• PhD (preferred), Masters or Bachelors in a relevant scientific discipline (such as Biotechnology, Bioprocess engineering, Immunology, Molecular Biology, Biochemistry)
• Years of relevant experience in industry as stated below:
• PhD with minimum of 7 years 
• Masters with minimum 12+ years 
• Bachelors with minimum 14+ years 
• 3+ years of hands-on analytical development experience is a must 
• Successful performance track record in establishing and applying analytical assays for cell therapy products or biologics. Direct analytical development experience for  clinical or commercial stage products is a plus
• Proficiency in multi- dimensional data analysis and interpretation using software such as Prism, R and/or JMP
• Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions; previous team management experience required
• Ability to lead successfully within extended project teams and handle multiple challenges under pressure
• Excellent communications and presentation skills, written and verbal
• Excellent organizational skills: Proactive, able to manage multiple tasks of varying complexity simultaneously