United States flag

Manager, Analytical Development

United States - California - Santa MonicaProcess/Product Development & OperationsRegular

Job Description


 

Manager, Analytical Development:

Kite’s Analytical Development team is seeking a highly motivated individual with sound laboratory, analytical sample testing and leadership experience, to contribute towards milestones on innovative cell therapies for cancer treatment. This individual will provide leadership to a team responsible for analytical testing of vector and T cell therapy products, contribute towards maturation of research analytical methodology needed for successful implementation into GMP release testing, and support the hiring/onboarding of new staff. He/she will also be responsible for reviewing/communicating critical study plan information to staff and directing day-to-day lab operations and analytical testing. The Manager will also provide oversight of laboratory studies, review of analytical data, ensure appropriate documentation, review/release testing results and provide troubleshooting, as needed. The Manager will also review and approve procedures, memorandums, SOPs and reports. Furthermore, they will work with other Analytical Development, Process Development,

Research and Quality Control leaders/teams on collaborative process improvements and platform innovations.

Key Responsibilities

  • Manage day-to-day analytical activities including timelines, testing plans, objectives setting and internal lab operations
  • Ensure standard operating procedures, analytical test methods, analytical sampling/testing plans and records meet the highest industry standards of excellence
  • Manage product/vector characterization and analytical activities, in support of vector and engineered immune cell product development
  • Engage within analytical development and cross-functionally with process development, manufacturing and Quality, to advance vector process development and T cell therapy programs
  • Evaluate existing/future analytical methods for vector and cell therapy products to identify improvements and opportunities for increased efficiency
  • Participate in development, review, and implementation of policies and procedures for existing and future operations, to enhance quality of support and efficiency
  • Support the ongoing development, implementation and maintenance of an appropriate staff training program, to ensure competency and compliance with Company SOPs, including staff training and relevant documentation, to maintain regulatory compliance
  • Support the Director, Analytical Testing and Logistics in the hiring/onboarding of new staff members
  • Provide input to develop budget and assure appropriate resourcing of the analytical development group
  • Help foster a collaborative work environment with key client groups in Research, Vector and T Cell Process Development, Quality and Manufacturing

Basic Qualifications

  • MS/MA in Biochemistry, Cell Biology or related discipline with 4+ years of related experience
  • BA/BS in Biochemistry, Cell Biology or related discipline with 6+ years of related experience
  • HS Diploma with 10+ years of related experience, will also be considered

Preferred Qualifications

  • Demonstrated experience in leading or managing an analytical testing team
  • Experience in analytical method development and optimization, technology transfer and method qualification/validation
  • Understanding of process development/pharmaceutical manufacturing of biotechnology products and cell therapy products
  • Previous experience in the analytical testing of cell therapy products, is a plus
  • Ability to lead a diverse, experienced technical staff team with attention to detail and mindfulness of staff career development
  • Proven ability to work effectively with both subordinate staff and senior level leaders
  • Ability to function efficiently in both team-based and independent roles, in a dynamic and ever-changing environment
  • Self-motivated, detail-oriented, excellent interpersonal communication and writing skills
  • Ability to think critically, and demonstrated troubleshooting and problem-solving skills
  • Willing to accept responsibilities outside of the initial job description
  • Proficiency with polychromatic flow cytometry, cell-based assays, qPCR/ddPCR and/or ELISA
  • Experience with data analysis software, such as JMP, is a plus.

#LI-ML1

#IND123