Assoc. Principal Scientist/Sr. Scientist- Process Engineering

We have a great opportunity to join the process engineering team as an Associate Principal Scientist (APS) or Senior Scientist.

AstraZeneca is a global, innovation-driven, biopharmaceutical company where we turn ideas into life changing medicines and strive to meet the unmet needs of patients worldwide. Pharmaceutical Technology and Development (PT&D) is the organization that turns brilliant science into actual medicines that help millions of people.

Inhalation Product Development in Gothenburg sits within PT&D and is responsible for the development of inhalation products including combinations. Inhalation Product Development is a multinational organization with decades of experience in inhalation technology and delivers the therapies of the future through scientific leadership in drug delivery, formulation and manufacturing of the final drug product.

You will join or lead matrix style project delivery teams and work closely together with scientists specialized in solid state analysis, material science, analytics and biopharmaceutics to achieve successful delivery of goals in drug product projects in the clinical phases as well as within innovation and feasibility projects.

To be successful in this role, we see that you have a strong scientific background with good communication skills.

What you'll do

This role requires a strong scientific background in the field of process engineering and the coming focus will be on spray drying development and manufacture of new modalities such as large biomolecules - proteins, oligonucleotides and RNA, as well as excipients and crystalline and amorphous small molecules, all in the field of inhalation.

You will be responsible for the application and development of process engineering to support drug product development. You will be active in the lab to progress the drug projects. You will bring clear conclusions to project teams, highlight risks and opportunities, and propose future steps.

As an APS, the role holder will provide process engineering and strategic input into pharmaceutical development delivery teams and to the formulation and process engineer community across PT&D. You will have a good working knowledge of product development, control strategy and lead to deliver the CMC aspects for projects to meet development timelines.

Key responsibilities

* Provide process engineering expertise and lead the design and experimental process engineering work.
* Plan and implement experimental work in alignment with project objectives, using both internal and external resources in delivering requested tox and clinical batches according to portfolio strategy as well as delivering in innovation and feasibility projects
* Evaluate data for trends indicative of product performance, method performance, or process performance. Author protocols and summary reports. Identifying aberrant data and provide solutions.
* Lead small cross-site and cross-functional groups of development scientists in a matrix style team
* Tackle complex scientific problems and provide lean and innovative solutions
* Clearly communicate plans, experimental data and conclusions to project teams + any risks and concerns to senior management.
* Delivering the project milestones according to the Product Development Process. Ensuring all documentation is in place on time and of high quality.
* Contribute to CMC project teams and documentation. Author sections of regulatory documents (e.g., IND/IMPD/NDA/MAA regulatory filings etc)
* Be a leader and role model for standard processes in the area of drug development, efficient work processes, and lab safety.

For APS, in addition to above

* Act as Subject Matter Expert and advisor as required across functional projects
* Give formulation strategic recommendations to projects related to technical and regulatory matters
* Collaborate broadly across PT&D with other scientists, giving input to science and innovation projects future strategic direction
* Coaching and developing colleagues, helping them to achieve their full potential within this field of expertise.

Essential Requirements

* Minimum BSc/MSc with proven working experience from industry in process engineering or a relevant field.
* Excellent understanding of the key technologies enabling inhaled product development, such as spray drying, capsule filling, micronisation and conditioning.
* Technical knowledge to improvement projects and the evaluation of new technology/processes.
* Strong oral and written communication skills and the ability to discuss complex ideas in a simple, easy to understand way.
* A proven track record of working collaboratively in a team environment to deliver project objectives

For APS, in addition to above

* Proven experience of leading technical packages and delivering within R&D in the pharmaceutical industry
* Demonstrated understanding of the link between process and drug product properties and a track record of impact projects in the area of process engineering during development or launch.
* Ability to lead multiskilled matrix teams for complex scientific projects
* Excellent communication and strategic influencing skills across scientific subject areas, cultures, functions and externally

Preferred Requirements

* Experience of pharmaceutical development and GMP work environment
* Experience from biomolecules in inhaled product development
* Proven track record in influencing product design using process engineering and experience of direct impact on decisions during product development.
* Experience of regulatory file submissions or agencies interactions.
* Previous experience of developing and using different predictive modeling tools
* Knowledge of tools for multivariate analysis, data visualization and predictive modelling packages.



So, what's next? We welcome your application no later than 6th June, 2023.