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AstraZeneca

Global pharmaceutical company developing prescription medicines

Associate Director Agile CMC Lead

Bioprocess & BiomanufacturingPosted on Nov 13
Full-timeGaithersburg, MD, USA

About the Job

Requirements

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

Responsibilities

  • Provide strategic CMC leadership for complex products and lead all aspects of CMC teams operating across the globe.
  • Develop agile, science-based strategies that support commercialization, lifecycle management, and supply continuity.
  • Collaborate with Technical Transfer, manufacturing, quality, regulatory, analytical, procurement, and distribution teams to solve CMC challenges and enable execution across the global network.
  • Coordinate and further a team spanning multiple geographies.
  • Lead Global CMC teams managing 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 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.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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