Director of Critical Reagents & Reference Standards- Gaithersburg, MD

At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.

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The Global Technical Operations (GTO) organization is seeking an experienced Director to manage and oversee the Critical Reagents and Reference Standards function. The Director will be responsible for operational oversight for critical reagent management across the organization working closely with AstraZeneca’s manufacturing network of internal sites and external manufacturing partners (CMOs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial . The successful candidate will lead the development of robust systems for the selection, qualification, monitoring, tracking, and storage of critical reagents to ensure delivery of quality products to our patients worldwide.

As Director of Critical Reagents & Reference Standards, you will be leading a strong technical team to support an exciting and continuously expanding biologics pipeline and global QC testing network at AstraZeneca. The leader will be responsible for building, developing, and coaching a team that can deliver continued supply of critical reagents and reference standards to both internal AstraZeneca and external testing locations such as CMOs and OTLs. This leader is also accountable to develop and establish new strategic capabilities for our global inventory management systems at AstraZeneca. In this capacity, you will work closely with QC testing sites (internal or external), other GTO functions, R&D, Quality, Regulatory, and Supply Chain organizations.

What you’ll do:

• Primary point of contact and owner for management of a robust system for the monitoring, tracking, and storage of critical reagents to ensure quality and commercial supply availability

• Develop and implement policies, procedures, and training programs to ensure compliance with regulatory requirements and industry best practices

• Support preparation of regulatory submissions, oversight during inspections and audits, and respond to questions from regulatory bodies within in the scope of critical materials and reference standards

• Collaborate with cross-functional teams to develop risk assessments and mitigation strategies for critical reagents

• Lead a team that is responsible for all aspects of development, implementation and management of the commercial global critical reagents and reference standard system at AstraZeneca. Specific activities would include inventory management, strategic planning, and lifecycle management of reference standards and critical materials.
• Monitor industry trends and advancements in critical reagent management and implement best practices to improve efficiency and effectiveness.

• Partner with team members from GTO, External Supply Manufacturing, and Global Supplier Quality for right first time delivery of critical materials and continued supply of critical materials.

• To succeed in this role, you will need to be self-motivated, innovative, have strong technical and communication skills, and a deep understanding of biologics quality control and quality requirements with an emphasis on application of those principles to critical materials.

Essential for the role:

• Degree in an engineering or scientific discipline with experience in materials management, quality systems and global regulatory requirements required:
  • B.S with 14+ years of experience
  • M.S. with 12+ years of experience
  • PhD with 10+ years of experience

• Experience building and managing high performing teams is required
• Technical knowledge of commercial biologics quality control testing for release, stability and regulatory submission support required. Prior experience with late phase biologics regulatory authority submissions required.
• Strong knowledge of global regulatory authority expectations and quality compliance with regard to critical materials including reference standards
• Ability to successfully influence across levels, across functions, with senior leaders and technical leaders. Strong communication skills.
• Ability to work in a complex, dynamic, global environment; thinking strategically and balancing both long and short-term priorities
• Ability to work on multiple projects and meet deadlines as needed; Emphasis on results-oriented, strong planning and execution skills
• Ability and willingness to travel ~10% to AstraZeneca sites in the US/ EU.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

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