Senior Director, Process Technology & Engineering

Senior Director, Process Technology & Engineering

Durham, NC- Emperor Boulevard

Global Product Development

Hybrid Work- on average 3 days a week from office

This role is an amazing opportunity to join the Process Technology and Engineering unit in Global Product Development, and taking responsibility for an organization of approximately 20-30 engineers across the US, UK and Sweden to design and scale up manufacturing processes for Oral and Inhalation drug products, as well as delivering successful technology transfer to commercial manufacturing sites.

What you'll do

• Provide both strategic and operational leadership to the Oral and Inhalation Process Engineering group, ensuring that the process and chemical engineering skill area contributes effectively to the delivery of the AZ late-stage development portfolio
• Manage a group of approximately 20-30 people via 5-6 direct reports both 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 the implementation of new practices that enable the group to achieve flexibility, agility, efficiency and delivery
• Develop and implement future focused, innovative and digitally orientated approaches to process engineering, using data science, predictive modelling and AI.
• Work in partnership with CMC Project Leadership to develop the strategy for the delivery of the project portfolio within their area of responsibility
• Set clear direction and objectives while motivating and engaging all staff

Essential for the role

• 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 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, skilled in influencing decisions across functions and organizational boundaries.

• Excellent communication and stakeholder-management skills, with the ability to set clear direction, communicate complex technical information, and engage effectively with senior leaders.

• Familiarity with how digital tools, data science, predictive modelling, automation, or artificial intelligence can assist product development.

Desirable for the role

• Advanced degree, such as a Master’s degree or PhD, in chemical engineering, pharmaceutical sciences, chemistry, or a related discipline.
• At least 15 years experience in CMC, pharmaceutical product development, process development, scale-up, or manufacturing science for synthetic molecules.

• Experience of continuous drug product processing, eg CDC

• Experience of 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.
  

Office Working Requirements

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

#LI-Hybrid 

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.