Senior Director, Drug Product Packaging and Tech Transfer

Senior Director, Drug Product Packaging and Tech Transfer

Location: Gaithersburg

Be a Catalyst for Change at AstraZeneca

Are you ready to lead with purpose and drive innovation that makes a global impact? Join AstraZeneca as our Senior Director, Drug Product Packaging and Tech Transfer, and play a vital role in delivering life-changing medicines to patients worldwide.

As part of our Global Technical Operations team, this leadership role puts you at the forefront of technological advancements, where you’ll shape cutting-edge solutions across modalities like biologics, vaccines, and combination products. Collaborating with a diverse network of experts, you’ll ensure the seamless validation and delivery of transformative therapies while building robust global supply chains.

Why Join Us?

At AstraZeneca, we’re united by a shared purpose: to push the boundaries of science to deliver medicines that transform lives. This role offers the opportunity to lead a world-class team, work on pioneering projects, and contribute to a culture of innovation, inclusivity, and collaboration.

Your Role at a Glance

As a key member of the Tech Transfer & Validation Leadership Team, you’ll bring vision and strategy to our technical projects. You will lead and inspire a team of subject-matter experts, collaborate across global functions, and champion advancements in sustainability, modernization, and operational excellence.

Key Responsibilities

Team Leadership

• Lead, mentor, and manage a team of 6–8 technical experts responsible for:

  • Overseeing commercial drug product tech transfer projects across internal and external sites within the global AstraZeneca network.

  • Driving validation activities including process validation, fill-finish, and shipping qualification for biologics drug product intermediates and finished goods.

Continuous Improvement & Innovation

• Foster a culture of innovation and continuous improvement by identifying opportunities to enhance technical and operational excellence.

• Leverage lean methodologies and risk-based approaches to optimize processes and deliver cutting-edge solutions.

• Champion digital transformation initiatives and collaborate across technical, quality, and leadership teams to implement innovative strategies.

Sustainability & Packaging Innovation

• Partner with design and engineering teams to develop a vision for sustainable packaging and shipping qualification practices that align with both environmental and business goals.

Global Best Practices

• Lead multi-disciplinary teams to establish and implement global best practices, guidelines, and training for tech transfer and validation processes.

Modernization & Operational Excellence

• Drive modernization efforts by authoring and updating procedures, incorporating state-of-the-art approaches, and streamlining processes using lean, risk-based methodologies.

• Establish priorities for Business Process Management, including:

  • Developing standardized “blueprints” for operational workflows.

  • Creating “playbooks” to align practices across global teams.

What You’ll Bring

Essential Skills and Experience

• Education:

  • Bachelor’s degree in engineering or a related field with 15+ years of relevant experience (graduate degree preferred).

• Technical Expertise:
  Proficiency in at least three of the following areas:

  • Large Molecule/Biologics drug product topics from development to GMP operations, including parenteral fill-finish, aseptic processing, lyophilization, and packaging.

  • Drug product transfer and validation/qualification processes, including packaging and fill-finish equipment.

  • Regulatory requirements and industry best practices for biologics drug product development, tech transfer, and supply chain establishment.

  • Business process excellence and operational optimization.

• Industry Experience:

  • Extensive experience within GMP development, logistics, scale-up, and/or manufacturing in the biopharma industry.

• Regulatory Knowledge:

  • Strong understanding of global validation life-cycle activities and compliance with regulatory and GDP standards.

• Leadership & Collaboration:

  • Demonstrated