Senior Director, Process Technology & Engineering

AstraZeneca • Durham, NC

6d • Hybrid

About The Position

The Senior Director, Process Technology & Engineering leads the Oral and Inhalation Process Engineering group within Global Product Development. The role is responsible for an organization of approximately 20–30 engineers across the US, UK, and Sweden, designing and scaling manufacturing processes for oral and inhalation drug products and delivering technology transfer to commercial manufacturing sites.

The position provides strategic and operational leadership to ensure the process and chemical engineering skill area contributes to the late-stage development portfolio. It guides teams across oral and inhalation projects, oversees the full drug product package within Module 3 of clinical and commercial regulatory submissions for 2–4 late-stage CMC projects, and partners with CMC Project Leadership on portfolio delivery strategies. The role also leads improvements in working practices and develops innovative, digitally oriented approaches using data science, predictive modelling, and AI.

The position is based in Durham, North Carolina, with hybrid working averaging three days per week in the office.

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 with oral and/or inhaled drug product development and a proven 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.
• Demonstrated people leadership, including the ability to motivate, empower, coach, and develop diverse teams across multiple locations and cultures.
• Strong knowledge of pharmaceutical sciences, including development of robust and scalable manufacturing processes and appropriate process control strategies.
• Experience collaborating within 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 robust 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 on 2–4 late-stage CMC projects.
• Lead implementation of practices that improve the group's flexibility, agility, efficiency, and delivery.
• Develop and implement innovative, digitally oriented approaches to process engineering using data science, predictive modelling, and AI.
• Partner with CMC Project Leadership to develop strategies for delivering the project portfolio within the area of responsibility.
• Set clear direction and objectives while motivating and engaging staff.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior