Senior Process Engineer

AstraZeneca • Durham, NC

7d

About The Position

The Senior Process Engineer will join the GPD Process Technology and Engineering Unit to support development of innovative inhaled and/or oral solid dosage products. The role leads process engineering activities across programs from early through late-stage development, helping shape product development strategies and designing and executing laboratory- and pilot-scale work packages. It also advances the use of in silico tools to accelerate development and improve process understanding.

Working in a multidisciplinary team, the engineer develops robust, well-understood, and well-controlled manufacturing processes intended to support long-term commercial performance and patient needs. The role partners across functions, takes ownership of technical work packages, and contributes to integrated drug product development plans under the guidance of senior staff.

Requirements

• Bachelor’s degree in a related discipline, such as Chemical Engineering or Chemistry, and at least 3 years of relevant industry experience.
• Experience in oral solid dose and/or inhaled drug product development.
• Experience in early- to late-stage product development, technology transfer, scale-up, and process validation.
• Fundamental understanding of control strategy and risk management.
• Basic understanding of predictive science, artificial intelligence, modelling, and simulation.
• Demonstrated understanding and application of digital tools and process models for development.
• Excellent communication and collaboration skills.

Nice To Haves

• Master’s or PhD in a related discipline.
• Experience with manufacturing processes and technologies relevant to oral solid dosage and/or inhaled products, including direct compression, wet granulation, roller compaction tableting, spray-drying particle engineering, pMDI manufacturing, or DPI manufacturing.
• Experience with regulatory authoring and defense.
• Experience with CMOs/CROs and outsourced development.
• Experience with regulatory submission authoring.
• Experience in process modelling or digital twin development.

Responsibilities

• Lead engineering work packages focused on designing and developing robust manufacturing processes for oral and inhaled products.
• Plan and execute lab-scale process development experiments to generate insights and inform project decisions.
• Help shape the scientific and technical direction of product development through strong process understanding and control.
• Define and optimize critical process parameters (CPPs) and integrate them into effective control strategies.
• Lead or contribute to technology transfer, risk assessment, process validation, and scale-up activities.
• Apply modelling, simulation, digital twins, and predictive tools to strengthen process understanding and accelerate development.
• Identify and solve complex technical challenges that affect project delivery.
• Champion creativity, innovation, collaboration, and scientific excellence.
• Partner across functions, own technical work packages, and contribute to integrated drug product development plans within a multidisciplinary team under the guidance of senior staff.

What This Job Offers

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