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Senior Process Engineer

AstraZeneca

Durham, NCOnsitePosted 15 days ago
Full TimeMid LevelManufacturing & CMCPharmaceutical
Original posting ↗

Summary

We are seeking a Senior Process Engineer to join our GPD Process Technology and Engineering Unit, supporting the development of innovative inhaled and/or oral solid dosage products.

Job description

In this role, you will lead key process engineering activities across an exciting portfolio of programs spanning early through late-stage development. As part of a multidisciplinary team, you will help shape product development strategies, design and execute laboratory and pilot-scale work packages, and advance the use of in silico tools to accelerate development and strengthen process understanding.

We are looking for a collaborative, solutions-focused engineer who thrives in a fast-paced scientific environment. You will play an important role in developing robust, well-understood, and well-controlled manufacturing processes designed to support long-term commercial performance and patient needs.

Key Responsibilities

  • Lead engineering work packages focused on the design and development of robust manufacturing processes for oral and inhaled products.
  • Plan and execute lab-scale process development experiments to generate insights and inform key 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 directly impact project delivery.
  • Champion a culture of creativity, innovation, collaboration, and scientific excellence.
  • Partner across functions and take ownership of technical work packages, contributing to integrated drug product development plans within a multidisciplinary team and under the guidance of senior staff.

Essential Skills and Experience

  • Bachelors Degree in Related Discipline (e.g - Chemical Engineering, Chemistry, or related field) with 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

Desirable Skills and Experience

  • Masters or PhD in related discipline
  • Experience with manufacturing processes and technologies relevant to oral solid dosage and/or inhaled products
  • Direct compression/wet granulation/roller compaction tableting
  • Spray drying particle engineering
  • pMDI or DPI manufacturing
  • Experience with regulatory authoring and defense.
  • Experience with CMOs/CROs and outsourced development.
  • Experience with regulatory submission authoring
  • Process modelling / Digital twin development

Requirements

  • Bachelors Degree in Related Discipline (e.g - Chemical Engineering, Chemistry, or related field) with 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

Company overview

AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines that create enduring value for patients, society, and shareholders. With a workforce of over 94,300 employees worldwide, the company operates across three core therapy areas: Oncology, BioPharmaceuticals (including Cardiovascular, Renal & Metabolism, Respiratory & Immunology), and Rare Disease. Headquartered in Cambridge, UK, AstraZeneca maintains strategic R&D centers in Cambridge, Gaithersburg (US), Boston (US), Gothenburg (Sweden), Shanghai, and Beijing. The company generated $54.1 billion in total revenue in 2024 and invested $13.6 billion in scientific research and development. AstraZeneca's bold aspiration is to be pioneers in science, lead in disease areas, and transform patient outcomes, with a goal to launch 20 new medicines and achieve $80 billion in total revenue by 2030. The company is recognized for its commitment to sustainability, health equity, and creating an inclusive work environment where diverse perspectives drive innovation.

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