Senior Director, Process Technology & Engineering

AstraZeneca•Durham, NC
•Hybrid

About The Position

The Senior Director will lead the Oral and Inhalation Process Engineering group within Global Product Development, overseeing approximately 20–30 engineers across the US, UK, and Sweden. The group designs and scales manufacturing processes for oral and inhalation drug products and supports successful technology transfer to commercial manufacturing sites. The role combines strategic and operational leadership to ensure process and chemical engineering capabilities support the late-stage development portfolio.

Requirements

  • Bachelor’s degree or equivalent in a relevant scientific or engineering discipline, such as chemical engineering, process engineering, pharmaceutical sciences, chemistry, or a related field.
  • At least 12 years of experience in CMC, pharmaceutical product development, process development, scale-up, or manufacturing science for synthetic molecules.
  • Substantial experience in oral and/or inhaled drug product development, with a track record of taking multiple products from late-stage clinical development through regulatory submission, technology transfer, process validation, and commercial launch.
  • Experience leading technical teams across late-stage development programmes and supporting regulatory submissions and commercialization activities.
  • People leadership experience, including motivating, empowering, coaching, and developing diverse teams across multiple locations and cultures.
  • Strong knowledge of pharmaceutical sciences, including development of robust, scalable manufacturing processes and appropriate process control strategies.
  • Experience working collaboratively in a matrix organization and influencing decisions across functions and organizational boundaries.
  • Excellent communication and stakeholder-management skills, including the ability to set direction, communicate complex technical information, and engage senior leaders.
  • Familiarity with how digital tools, data science, predictive modelling, automation, or artificial intelligence can assist product development.

Nice To Haves

  • Advanced degree, such as a Master’s degree or PhD, in chemical engineering, pharmaceutical sciences, chemistry, or a related discipline.
  • At least 15 years of experience in CMC, pharmaceutical product development, process development, scale-up, or manufacturing science for synthetic molecules.
  • Experience with continuous drug product processing, such as CDC.
  • Experience in parenteral drug product development.
  • Knowledge of relevant GMP, regulatory, quality, and process validation requirements for oral and inhalation drug products.
  • Experience applying digital tools, data science, predictive modelling, automation, or artificial intelligence to process development and engineering.
  • Experience working with external manufacturing partners, contract development and manufacturing organizations, or commercial manufacturing sites.

Responsibilities

  • Provide strategic and operational leadership to the Oral and Inhalation Process Engineering group.
  • Manage approximately 20–30 people through 5–6 direct reports, including succession and workforce planning.
  • Guide teams in developing strategies to deliver late-stage development goals across oral and inhalation projects.
  • Take responsibility for the full drug product package within Module 3 of clinical and commercial regulatory submissions for 2–4 late-stage CMC projects.
  • Lead implementation of practices that improve the group’s flexibility, agility, efficiency, and delivery.
  • Develop and implement future-focused, innovative, digitally oriented process engineering approaches using data science, predictive modelling, and AI.
  • Partner with CMC Project Leadership to develop strategies for delivery of the project portfolio in the area of responsibility.
  • Set clear direction and objectives while motivating and engaging staff.
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