Associate Principal Scientist, Vector Design

Role Summary

A highly motivated, experienced and strategic Associate Principal Scientist, Vector Design to join the Viral Vector New Modality group within AstraZeneca’s Process Science and Technology (PSAT), Cell Therapy Development and Operation (CTDO). The successful candidate will lead viral vector process development projects to meet quality, regulatory, and business goals on time, coordinate cross-functional teams, manage timelines and resources, and communicate progress to stakeholders. This role can be based in Santa Monica, CA or Gaithersburg, MD.

Responsibilities

• Viral vector process design: Leading, supporting the design and development of scalable, cost-effective, GMP-compliant LVV manufacturing processes to support ex vivo and in vivo cell therapy programs
• Project planning and execution: Initiating, planning, and overseeing the entire viral vector process development project lifecycle, from concept through lab build to manufacturing tech transfer
• Cross-functional team leadership: Managing and aligning diverse teams, including scientists and engineers, to ensure project goals are met
• Technical oversight: Partnering with technical leads to define deliverables, troubleshoot issues, and ensure the scientific and technical aspects of process development are sound
• Timeline and budget management: Developing and managing project timelines, adjusting as needed, and ensuring the project stays within budget
• Regulatory compliance: Ensuring all project activities adhere to GMP and ICH guidelines
• Stakeholder communication: Serving as the main point of contact, providing updates to clients and internal stakeholders, and managing project communications
• Supply and lab management: Managing vendors/suppliers/service providers to ensure smooth viral vector lab operations as needed

Education And Experience

• PhD in relevant Engineering or Science majors and 5+ years of related industry experience or MS with 8+ years of related industry experience; cell and gene therapy experience preferred
• Title will be commensurate with qualification and experience

Preferred Qualifications

• Previous experience in viral vector or CAR-T process development and project management
• Experience managing scale-up, tech-transfer, and implementation of manufacturing processes at internal and external manufacturing partners
• Knowledge of cGMP and Quality systems requirements, FDA guidance relevant to gene and cell therapy
• Proven ability to manage matrixed projects and tasks to completion, anticipating and elevating risks and obstacles, and adjusting to effective contingency plans
• Strong organization and record-keeping skills, including ability to manage multiple responsibilities in parallel
• A highly collaborative working style, track record of successful performance in a matrixed team environment
• Strong soft skills including communication, leadership, adaptability, and problem-solving skills