Biopharmaceutical Modelling Expert in Inhaled Drug Delivery

We seek a talented and motivated Biopharmaceutics Scientists with a background in mathematical modelling to strengthen the Biopharmaceutics team in the Inhalation Product Development unit in Gothenburg, Sweden.

As a Biopharmaceutics Scientist you are expected to provide drug project teams with an assessment on how the properties of the inhaled drug product (and changes thereof) are likely impacting its safety, therapeutic efficacy and pharmacokinetics in patients. With your background in mathematical modelling you will be responsible for leading the development and application of in silico modelling tools to enable such assessment. This is an exciting role and environment where you will work across the borders of numerous AstraZeneca functions supporting the development of the next generation of inhaled drugs.

Pharmaceutical Technology & Development (PT&D) is a global function tasked with design, development, commercialization and support of AstraZeneca's medicines and reports to the EVP of Operations. Inhalation Product Development (IPD) in Gothenburg sits within PT&D and is responsible for the development of inhalation products including combinations.

In this role, you will have responsibilities for inhaled formulation and drug product designs and in vivo product performance, considering how the drug product should be optimally designed for efficient and robust delivery to the lung target site, ensuring optimal outcomes in clinical programs. Specific focus is put on the changes in drug product that typically occurs between different phases of clinical development as the product moves towards registration and launch. Changes in in vitro properties such as aerosol performance can result in altered total and regionally deposited drug dose in the lung and therefore alter measures of in vivo performance e.g., pharmacokinetic profile.

We are looking for candidates with strong skills in mathematical modelling who has a proven interest of, or preferably pre-existing experience in, developing and applying mathematical modelling techniques in areas of relevance to biopharmaceutics: chemistry, physics, biology, and medicine. The candidate should have inclination and ability to collaborate and partner with experimentalists and domain experts and deliver as a team.

The career level of the position will be set according to the qualifications of the successful applicant.

What you'll do

You will work closely with a multidisciplinary team composed of formulators, analyst, solid and material state experts and you are expected to take a holistic view of chemical manufacturing and control (CMC) activities as well a working knowledge of other scientific disciplines such as safety assessment, clinical pharmacology and pharmacokinetics.

The mechanistic models you will be working with and develope will include mathematical descriptions of 1) aerosol deposition in the lung, 2) particle dissolution, 3) the molecule´s permeation into and distribution withing lung tissue and 4) subsequent transport to blood and whole-body pharmacokinetics. It will be your responsibility to foresee this and develop mitigation strategies to enable leveraging of previously established safety and efficacy of the drug so as to minimize delays in the program. You are expected to present your work to internal governance bodies and to regulatory authorities. Furthermore, inhaled biologics and other non-small molecules represent emerging and novel types of inhaled drugs. In this space you, as biopharmaceutics expert, will be evaluating the role of excipients to deliver and stabilize the drug protein at the target site.

Essential Requirements

* Ph.D. degree in a relevant discipline (such as engineering, mathematics, biopharmaceutics, pharmaceutics, or pharmacokinetics) or equivalent industrial experience within pharmaceutical drug development.
* Strong experience in one of the following areas of mathematical modelling: physiologically-based pharmacokinetics /biopharmaceutics, computational fluid dynamics of aerosols, systems biology, systems pharmacology.
* Ability to quantitatively address uncertainty of model predictions and parameter estimates.
* Proven interest and ability to address new scientific problems by mathematical modelling.
* Ability to judge what types of problems are more/less likely to be successfully addressed by mathematical modelling.
* Excellent verbal and written communication skills.
* Ability and inclination to work collaboratively in a team.
* Documented independence in driving a research project.

Desirable Requirements

* Track record of scientific excellence in terms of publications, presentations and networking activities.
* Capable of, and desire for continuing to develop yourself in this area.
* Experience of lung deposition modelling.
* Experience of characterisation of protein stability.
* Experience of using physiologically-based pharmacokinetic/biopharmaceutic modelling in regulatory submissions.
* Good understanding/knowledge of the overall drug development process and knowledge of what CMC attributes that make this process successful.
* Track record of design of active pharmaceutical ingredients based on expert knowledge of how material and molecular properties interact to provide an optimal inhaled medicine.
* Familiar with ICH guidelines, USP/EP requirements, and FDA/EU guidance on inhalation dosage forms.

So, what's next! We welcome your application no later than Jan 30th, 2023.

Screening interviews can be held during the application period.