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AstraZeneca

Global pharmaceutical company developing prescription medicines

Senior Director - Process Technology & Engineering

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeDurham, NC, USANo salary listed

About the Job

Requirements

  • A 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 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.
  • Demonstrated people leadership experience, including the ability to motivate, empower, coach, and develop diverse teams across multiple locations and cultures.
  • Strong knowledge of pharmaceutical sciences, including the development of robust and scalable manufacturing processes and appropriate process control strategies.
  • Experience working collaboratively within a matrix organisation and influencing decisions across functions and organizational boundaries.
  • Familiarity with how digital tools, data science, predictive modelling, automation, or artificial intelligence can assist product development.

Responsibilities

  • Provide strategic and operational leadership to the Oral and Inhalation Process Engineering group, ensuring the process and chemical engineering skill area contributes effectively to delivery of the late-stage development portfolio.
  • Manage approximately 20–30 people through 5–6 direct reports locally and globally, 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 new practices that enable the group to achieve flexibility, agility, efficiency, and delivery.
  • Develop and implement future-focused, innovative, digitally oriented approaches to process engineering using data science, predictive modelling, and artificial intelligence.
  • Partner with CMC Project Leadership to develop the strategy for delivering the project portfolio within the area of responsibility.
  • Set clear direction and objectives while motivating and engaging all staff.

Desired Qualifications

  • An 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.

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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