Senior Director, Drug Product and Packaging Tech Transfer

Senior Director Drug Product and Packaging 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 ourSenior Director Drug Product and Packaging Tech Transfer and play a vital role in delivering life-changing medicines to patients worldwide.

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

Why Join Us

At AstraZeneca were 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 theTech Transfer & Validation Leadership Team youll 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 68 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 forBusiness Process Management including:

  • Developing standardized blueprints for operational workflows.

  • Creating playbooks to align practices across global teams.

What Youll Bring

Essential Skills and Experience

• Education:

  • Bachelors 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 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

Closing Date