Executive Director Viral Vector Development and New Delivery Modalities - Cell Therapy Operations

If you have the passion and the drive to accelerate growth and make people’s lives better – then AstraZeneca is the place for you.  In Operations we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking. 

AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery.  Operations is accelerating, fast. We are on track for Our Bold Ambition 2030, delivering 15+ new medicines driving us forward across different modalities including biologics, cell therapy, ADCs and small molecules. 

Position Summary

The Executive Director, Viral Vector Development and New Delivery Modalities reports into the Vice President, Analytical and Process Development.  The position is located in Gaithersburg, MD or Santa Monica, CA. 

Executive Director, Vector Development leads the strategy, development, and implementation of viral vector processes for therapeutic use, often in the context of gene therapy or cell therapy. They are responsible for overseeing a team of scientists and engineers.

The Executive Director will provide will lead the strategy, development, and implementation of viral vector processes for therapeutic use in the context of gene therapy or cell therapy.  The ideal candidate will be responsible and accountable for vector process development and GMP Phase I to III manufacturing protocols, as well as establishing production procedures including new delivery modalities. This position will oversee a team of scientists and engineers driving innovation in vector technology, ensuring regulatory compliance, and supporting the advancement of products through the development and commercialization lifecycle. This role requires a strong understanding of cGMP regulations, drug development processes, and the ability to collaborate effectively with cross-functional team.

Responsibilities

• Develop strategic plans for vector process development in alignment with organizational goals and regulatory requirements.

• Lead and drive the development of viral vector-based (e.g., lentivirus, AAV) manufacturing processes and new delivery modality to improve efficiency, scalability, and product quality, with a focus on innovation and optimization.

• Design and oversee experiments to evaluate and improve viral vector production processes, utilizing statistical methods and experimental design principles.

• Assist in developing budget projections, material and staffing forecasts

• Manage the transfer of plasmid and viral vector processes from research and development to manufacturing, ensuring seamless integration and compliance with regulatory standards.

• Ensure all process development activities comply with relevant regulatory guidelines (FDA, EMA, etc.).

• Maintain rigorous quality control standards throughout the process development lifecycle.

• Prepare and review documentation for regulatory submissions and audits.

• Ensure sound design and process characterization studies to develop a thorough understanding of late-stage Manufacturing process to support success transfer and launch of new products.

• Collaborate with manufacturing teams to troubleshoot and resolve production issues.

• Work closely with internal departments (e.g., Quality Assurance, Quality Control, Manufacturing) to align process development

• Communicate project progress, challenges, and strategic plans to senior management and stakeholders.

• Stay abreast of industry trends and advancements to enhance AZ virus-related capabilities.

Preferred Requirements

• Advanced degree (e.g., MS/Ph.D.) in a relevant scientific field (e.g., Chemical Engineering, Biochemistry, Virology).

• Extensive experience (typically 15+ years) in viral vector process development and manufacturing, ideally in the biopharmaceutical industry.

• In-depth knowledge of cGMP regulations and regulatory requirements for biologics/cell & gene therapy products.

• Proven track record of leadership and successfully managing teams.

• Strong communication, interpersonal, and presentation skills.

• Ability to work effectively in a fast-paced, dynamic environment. Experience with regulatory filings (e.g., IND/CTA, BLA/MAA) preferred.

Skills and Competencies

• Expert in Mechanism of Action (MOA) for defining Critical Quality Attributes (CQAs) and developing Quality by Design (QbD) control strategies for cell therapy or biologic