Senior Director, Drug Substance Validation and Tech Transfer

Senior Director, Drug Substance Validation and Tech Transfer

Location: Gaithersburg

Shape the Future of Biologics at AstraZeneca

Are you ready to lead with purpose and drive innovation that transforms lives?

Join AstraZeneca as our Senior Director, Drug Substance Tech Transfer and Validation and take on a pivotal leadership role in delivering life-changing medicines to patients worldwide.

As part of our Global Technical Operations team, this role places you at the forefront of scientific and operational excellence. You’ll lead groundbreaking initiatives across our biologics pipeline, ensuring seamless drug substance transfers and validations that support the delivery of transformative therapies.

Why AstraZeneca?

At AstraZeneca, we are united by a shared purpose: to push the boundaries of science and deliver medicines that change lives. This role offers the opportunity to lead a highly skilled team, collaborate across global functions, and contribute to a culture of innovation, collaboration, and sustainability.

Your Role at a Glance

As a member of the Tech Transfer & Validation Leadership Team, you’ll provide visionary leadership to a team of experts while collaborating with cross-functional partners. Your efforts will drive technical excellence, ensure compliance with global regulatory standards, and establish best practices to modernize and optimize our global supply chains.

Key Responsibilities

Team Leadership

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

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

  • Driving shipping qualification activities for biologics drug substance (DS) and drug product (DP) to establish robust global supply chains.

Continuous Improvement & Innovation

• Cultivate a culture of continuous improvement by identifying and translating opportunities into actionable plans.

• Lead initiatives to enhance operational efficiency using lean methodologies and risk-based approaches.

• Collaborate across technical, quality, and leadership teams to deliver innovative strategies and drive digital transformation.

Sustainability & Packaging Innovation

• Develop and implement a vision for sustainable packaging engineering and shipping qualification practices.

• Partner with stakeholders to align technical solutions with environmental and business goals.

Global Best Practices

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

Modernization & Operational Excellence

• Champion modernization by authoring and updating procedures and guidelines to reflect state-of-the-art approaches.

• Streamline processes using lean, risk-based methodologies and establish priorities for Business Process Management, including:

  • Developing standardized “blueprints” for operational workflows.

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

What You’ll Bring

We’re looking for an experienced leader who thrives in dynamic environments, inspires teams, and drives innovation.

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 the following areas:

  • Drug substance manufacturing, including cell culture, media/raw materials, downstream purification, and process analytical technologies. Experience in fermentation, continuous manufacturing, and conjugation is a plus.

  • Engineering of packaging and shipping solutions for biologics drug substance.

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

  • Business process optimization, operational excellence, and project management.

• Industry Experience:

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

• Regulatory Knowledge:

  • Strong understanding of qualification and packaging life-cycle activities, including compliance with global regulatory requirements 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 capacity to influence, collaborate, and build consensus across multi-disciplinary teams.

Preferred Skills and Experience

• Advanced degree (PhD strongly preferred).

• Experience with emerging 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 Project/Portfolio Management, Lean, or Six Sigma methodologies.

• Expertise in temperature-controlled transport, packaging, and monitoring solutions.

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.