Associate Principal Scientist - Formulation and Process Design

About AstraZeneca:

AstraZeneca is a global, science-led biopharmaceutical company and our innovative medicines are used by millions of patients worldwide. This is the place to make an impact. Here we ensure everyone can reach their full potential, perform at their best and make a valued contribution to the enterprise!

About Pharmaceutical Technology & Development (PT&D) and Global Product Development (GPD):

PT&D is the bridge that turns brilliant science into real medicines, spanning the entire value chain-from early toxicology and clinical supplies to technology that enables robust commercial manufacture. Within PT&D, GPD leads the late-stage design and development of drug products across a range of dosage forms. We develop the formulation, manufacturing process, and scientific understanding needed to scale, launch, and sustain new medicines. You’ll collaborate in highly multidisciplinary teams with engineers and pharmaceutical scientists to advance life-changing medicines for patients.

The Opportunity:

We are seeking an Associate Principal Scientist within Formulation and Process Design, that can balance formulation development and process engineering with a passion for application of digital tools with experience in solid dosage product development (tablets, capsules).

In this role you will work closely with a team of colleagues in a multi-disciplinary environment to assess, design, develop and deliver high quality clinical and commercial formulations and processes. You can expect to contribute to programs at laboratory scale with line of sight for commercial manufacture by using modelling and simulation approaches as first intent combined with hands-on experimental work as needed. You will play a key role in leading the formulation aspects of projects in late-stage development spanning an exciting portfolio of oral solid dosage forms (including Continuous Direct Compression). You will be an important member of a multidisciplinary team, providing input to the overall product development, designing and executing lab based and pilot plant work packages and driving the development and implementation of in silico tools to support and accelerate development.

You will be a recognized problem solver and team player who thrives under pressure and has a passion for ensuring product robustness through the development of manufacturing processes which are well understood, controlled, and capable of meeting long-term commercial and patient needs.

Key Responsibilities:

• Lead formulation input for the design and development of robust oral solid dosage forms.
• Lab-based formulation and process development: plan and execute lab-scale experiments to facilitate project decisions.
• Shape the scientific and technical direction of product development activities through formulation understanding and process design and control.
• Help define and optimize critical process parameters (CPPs) and integrate them into control strategies.
• Lead or contribute to technology transfer, risk assessment, process validation and scale-up.
• Apply modelling, simulation, digital twins and predictive tools to enhance process understanding.
• Solve key technical challenges with direct impact on current project delivery.
• Drive a culture of creativity, innovation and scientific excellence.
• Cross-functional collaboration: Contribute to integrated drug product development plans within a multidisciplinary team.
• Work hands-on to generate data as well as work collaboratively with other experimentalists with different backgrounds to identify/use/drive digital applications as first intent to strategically direct experimentation.
• Be part of cross-functional project teams focusing on developing drug products ranging from both early to late-stage development.
• Be a key player to drive and further develop the digital transformation within Formulation & Process Design (FPD).
• Establish strong working relationships with the Modelling & Simulation team members and with other colleagues in Global Product Development to enable an impact-driven application of modelling and simulation tools.
• Manage your own work to achieve drug development and improvement project targets, in a timely fashion, and to agreed quality standards, by applyingtechnical knowledge and expertise as well as interpreting results and adapting investigations as appropriate.
• Participate in scientific and/or technology networks to increase base-line knowledge and create awareness of new developments in relevant areas

Essential Skills and Experience:

• Bachelor’s degree in Related Discipline (e.g - Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences) with 5 - 10 years of relevant industrial experience.
• Experience in oral solid dose development.
• Experience in late-stage product development, technology transfer, scale-up and process validation.
• Strong interest in applying modelling and simulation to deliver value in transferring projects from early to late phase development of pharmaceutical drug products.
• Fundamental understanding of control strategy and risk management.
• Basic understanding of predictive science, artificial intelligence, modelling and simulation.
• A rational approach to problem solving, and an ability to make judgements based on sound reasoning.
• Operates confidently and collaboratively within a global organization, with an integrating mind-set

Desirable Skills and Experience:

• Masters or PhD in Life Sciences (e.g. - Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences).
• Experience formulating/Drug Product development for a range of oral solid dosage units and operations e.g. continuous manufacturing, granulation, compression, coating.
• Experience of applying modelling and simulation tools
• Experience with regulatory authoring and defense.
• Experience with CMOs/CROs and outsourced development.

The annual base pay for this position ranges from$138 K to $207K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

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.