Associate Director Agile CMC Lead, US

Job Summary

As the Associate Director Agile CMC Lead, US, you will provide strategic CMC leadership for complex products and lead all aspects of CMC teams operating across the globe. You will develop agile, science-based strategies that support commercialization, lifecycle management, and supply continuity.

Collaborating with Technical Transfer, manufacturing, quality, regulatory, analytical, procurement, and distribution, you will help solve complex CMC challenges and enable effective execution across the global network. You will also coordinate and further a team spanning multiple geographies.

What you'll Do

• Lead Global CMC teams managing sophisticated products through their creation, market introduction, and ongoing management.
• Develop agile CMC strategies that address technical, operational, and supply challenges.
• Lead continued process verification (CPV), validation, alternate raw material, and shipping validation strategies related to drug substance (DS) and final medicinal products.
• Partner with Technical Transfer teams to align CMC strategy with technology transfer, validation, comparability, process performance, and site readiness.
• Work with the Global Logistics Function and supply chain teams to coordinate CMC decisions with logistics, shipping, material flow, and supply needs.
• Bring together development, manufacturing, quality, analytical, logistics, and operations perspectives to overcome advanced CMC obstacles
• Communicate CMC strategies clearly and influence across functions and organizational boundaries.
• Lead and develop a team operating across multiple regions, encouraging collaboration, accountability, inclusion, and strong performance.
  

Essential Requirements

• Degree in a relevant scientific or engineering discipline.
• Significant CMC leadership experience within the biopharmaceutical industry.
• Experience supporting complex products across development, commercialization, and lifecycle management.
• Experience leading Global CMC teams and working with Product Champions and senior cross-functional partners.
• Strong knowledge of CMC strategy, validation, ongoing process monitoring, comparability, raw material strategy, and supply-related technical considerations.
• Experience across drug substance and drug product operations, including technical transfer, validation, and shipping considerations.
• Experience working across Technical Transfer, manufacturing, analytical, quality, supply chain, and logistics functions.
• People leadership experience, including leading teams across multiple geographies.
• Strong communication and influencing skills, showing proficiency in aligning teams and driving decisions across organizational boundaries.
• Cultural awareness and the ability to work effectively across regions, perspectives, and working styles.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and spark your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

The annual base pay for this position ranges from $138,392.80-$207,589.20 Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. ​

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Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

About Us

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We

focus on discovering, developing and commercialising prescription medicines for some

of the world’s most serious diseases. But we are more than one of the world’s leading

pharmaceutical companies.

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered

to push the boundaries of science, challenge convention and unleash your entrepreneurial

spirit. To embrace differences and take bold actions to drive the change needed to meet

global healthcare and sustainability challenges.

There is no better place to make a difference in medicine, patients, and society. An inclusive

culture where you will connect different thinking to generate new and valuable opportunities.

Where you will find a commitment to lifelong learning, growth and development for all.

Championing Inclusion and Diversity

Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients.

Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.

Life at AstraZeneca

We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions.

As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential.

Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.