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 ability to lead diverse, cross-functional teams and inspire innovation in a global, matrixed environment.

  • Exceptional interpersonal skills, with the ability to influence and build consensus across teams.

Preferred Skills and Experience

• Advanced degree (PhD strongly preferred).

• Experience with new modalities (e.g., ADCs, radioconjugates, cell therapies).

• Familiarity with digital transformation tools (e.g., process modeling, product lifecycle management, data visualization).

• Certification or experience in Lean, Six Sigma, or Project/Portfolio Management.

• Expertise in temperature-controlled transport and logistics qualification.

The annual base pay for this position ranges from $179K to $269K. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.  ​

Date Posted

13-Jan-2025

Closing Date

26-Jan-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.