Biopharmaceutical Modelling Expert in Inhaled Drug Delivery

Biopharmaceutical Modelling Expert in Inhaled Drug Delivery

Would you like to make use your scientific expertise and skills in mathematical modelling to guide inhaled drug product design and development strategies? Join us at AstraZeneca, a place built on innovation and creativity.

We now 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.

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. We are proud to be a great place to work and have a culture that inspires innovation and collaboration.

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.

What you'll do

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. 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 potentially also 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.

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.

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.

Minimum 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: computational fluid dynamics of aerosols, molecular modelling, physiologically-based pharmacokinetics /biopharmaceutics, systems biology, systems pharmacology.
* 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 successful driving a research project.

Preferred 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 June 13th,2022.

Screening of applications and interviews can be done during the application period.