Senior Scientist Biopharmaceutics in Inhaled Drug Delivery

We now seek motivated Biopharmaceutics Scientists to join the Formulation & Biopharmaceutics team in the Inhalation Product Development unit in Gothenburg, Sweden.

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 in Gothenburg sits within PT&D and is responsible for the development of inhalation products including combinations. Inhalation Product Development deliver the therapies of the future through scientific leadership in drug delivery, formulation and manufacturing the final drug product. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

As a Biopharmaceutics Expert you are anticipated to provide biopharmaceutics input into respiratory development projects by independently leading method development and research projects within the area of inhalation biopharmaceutics.

This is an exciting role where you will act as a key member of various project teams and provide your scientific expertise into formulation design and development strategies.

The role
You will have responsibilities for inhaled formulation designs and in vivo product performance, considering the optimal drug delivery to reach the target pharmacokinetic profile and desired clinical outcome, primarily in clinical programs. To do this successfully 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 CMC activities as well a working knowledge of other scientific disciplines within BioPharma R&D to deliver innovative and differentiated strategies that balance scientific risks against return on investment.

We are looking for candidates with previous experience in supporting inhaled projects and who has a strong understanding of biopharmaceutics, physical chemistry and biology to enable a mechanistic understanding of in vivo drug product performance.

In addition to being able to provide relevant and timely biopharmaceutics support to drug projects, the successful candidate will have the background and skills to drive platform (cross-project) research in either of the following two areas:

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modulation of regional deposition of inhaled drug products by design of formulation and device, or
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addressing the fate of inhaled biologics in vivo, including API and drug product physico-chemical characterization in silico and in vitro, e.g. particle dissolution, solubility, protein aggregation and pre-systemic clearance mechanisms.

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

Minimum Requirements - Experiences, Skills and Capabilities

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Ph.D degree in a relevant discipline (such as Biopharmaceutics, Pharmaceutics, Engineering, Pharmacokinetics or Drug Delivery) or equivalent industrial experience within inhaled pharmaceutical drug development.
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Working knowledge of mathematical modelling and simulation of biopharmaceutics in platform models (e.g. GastroPlus, SimCyp, or other).
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Good understanding of biopharmaceutics and pharmacokinetics.
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Practical experience in the use of in vitro and in vivo methodologies to support drug development.
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Experience of predictions of pre-clinical and clinical performance of drug products based on in vitro as well as in vivo data using mechanistic in silico models.
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Documented independence in successful driving a research project.

Preferred Requirements - Experiences, Skills and Capabilities

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Innovative, with a passion driving scientific excellence and a continuous improvement mind-set.
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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.
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Strong skills in mathematics, mathematical modelling and Computational Fluid Dynamics (CFD) for applications related to inhaled drug deposition modelling.
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Experience of characterisation of protein stability.
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Good understanding/knowledge of the overall drug development process and knowledge of what CMC attributes that make this process successful.
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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.
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Experience of supporting clinical studies design based on expert knowledge on clinical trial material performance.
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Familiar with ICH guidelines, USP/EP requirements and FDA/EU guidance on inhalation dosage forms.



More information
For more information, please contact Antonio Llinàs: Antonio.Llinas@astrazeneca.com.

Welcome with your application no later than 31 August.

AstraZeneca: https://www.astrazeneca.com/
Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html
Life in Gothenburg: https://www.movetogothenburg.com/