Ph.D. position Biopharmaceutical Investigations of Long Acting Injectable S at SDU Career Site

Odense, Region of Southern Denmark, Denmark -

Full Time

Start Date

Immediate

Expiry Date

01 Mar, 26

Salary

0.0

Posted On

01 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmaceutical Formulation, Formulation Characterization, Suspensions, Particle Size Characterization, Bioanalysis, In Vivo Studies, Quality by Design, Risk Assessment, Formulation Understanding, Robust Design, Physiological Based Pharmacokinetic Modelling, Independent Work, Fluency in English

Industry

Higher Education

Description

A Ph.D. position within formulation characterization focused on biopharmaceutical investigations of long acting injectable suspensions is available at the Department of Physics, Chemistry, and Pharmacy in the pharmacy research group. Project background Long acting injectables (LAIs) are pharmaceutical products intended for weekly, monthly or with an even lower administration frequency, which provides a continued drug release and thereby a steady exposure of the delivered compound. LAIs are typically administered intramuscularly (IM) or subcutaneously (SC) as oil solutions, in situ forming gels, microspheres, implants, micro- or nanosuspensions, with focus on suspensions in the present work. For individuals suffering from dysphagia or chronic disease where limited patient adherence may have a negative outcome on the treatment efficacy, LAIs can provide a huge benefit in disease treatment. The incidence of chronic illnesses and of dysphagia is significantly growing in our ageing population. For this reason, many disease areas may benefit from the constant drug delivery that a LAIs formulation may offer. LAIs have, with huge clinical success, been applied in the treatment of antipsychotic conditions and the area contains some of the most successful LAI formulations seen from a therapeutic perspective. In the 1960s, oil-based parenteral depot formulations, containing antipsychotics, were introduced in the clinical practice. Since then, the micro- and nanosuspension technology has significantly advanced and many of the more recent LAIs are nano-or microsuspensions. Hence, this is currently one of the important technologies in the field of LAIs. The common approach to manipulate the performance of LAI suspensions release rate relies on changing particle size distribution of the crystalline API. This strategy is fundamentally explained by the Noyes-Whitney equation, which describes the dissolution rate of particles in sink conditions. According to the Noyes-Whitney equation, the dissolution rate is proportional to the total surface area of the drug particles. Some commercial products confirms thus and also a few academical studies have reported correlations between the particle size and the in vivo release, hence it is clearly a point that should be clarified when working with a new compound for a LAI suspension. Aside from particle size, other formulation aspects can significantly impact performance, such as formulation composition and the level of flocculation. In addition, API crystal form properties, such as morphology, level of amorphous contents and residual solvent in the API, may have a significant impact on dissolution, indicating that the selection of version and form is crucial not only for manufacturability and stability purposes, but also for performance. This project aligns closely with Quality by Design (QbD) principles, emphasizing risk assessment, formulation understanding, and robust design space development, but systematically investigating the formulation impact on in vivo release of LAI suspensions in nonclinical models using the obtained data to generate a risk matrix for in vivo impact of potential particle size variations. A successful outcome of this project will provide pharmaceutical scientists with the tools to understand the biopharmaceutical performance of LAI suspensions supported by quality tools as well as physiological based pharmacokinetic modelling platforms. Qualifications We are looking for a candidate with a strong interest in working with pharmaceutical formulation and evaluation focused on formulation and characterization of suspensions. The candidate will hold a M.Sc. in pharmacy, chemistry, physics, or closely related area. Previous experiences with one or more of the following are considered an advantage: formulation design of suspensions, particle size characterization, bioanalysis, in vivo studies. The candidate must be independent and fluent in English both orally and written. For further information about the position please contact Professor René Holm (reho@sdu.dk). Starting date: 01 February 2026, or as soon as possible thereafter. The Department of Physics, Chemistry and Pharmacy is one of four departments at the Faculty of Science, SDU and is located in Odense. At the Department of Physics, Chemistry and Pharmacy, we contribute to solving some of society’s greatest challenges within energy, environment, health, and sustainability. We succeed because we build bridges between disciplines and transcend traditional boundaries. Our interdisciplinary mindset is not only a fundamental condition, but also our strength. And it is a strength that ensures our research and education are recognized both nationally and internationally. Our vision is to create and apply knowledge across the natural sciences. We are unique in housing research within physics, chemistry, and pharmacy under one department, which provides excellent opportunities to explore the intersections between these disciplines. Read more about the Ph.D. program at the Department. Application, salary etc. Appointment as a PhD Research Fellow is for three years. Employment stops automatically at the end of the period.(the 5+3 programme). Further information about the PhD programme at the Faculty of Science can be found at the homepage of the University. The University wishes our staff to reflect the diversity of society and thus welcomes applications from all qualified candidates regardless of personal background. Application must be in English and made in the form of a Declaration of Interest including the following: A letter stating your specific interest, motivation, and qualifications for the project in question (max. two pages) . Detailed CV, including personal contact information and date entries Copies of diplomas, Bachelor as well as Master’s degree, including transcript of notes/grades. The names and complete contact details (phone numbers and e-mail) of at least two referees details for at least 2 referees who can vouch for your skills. Shortlisting may be used in the assessment process. Incomplete applications and applications received after the deadline will neither be considered nor evaluated. This also applies to reference letters. Applications will be assessed by an expert assessor/committee. Applicants will be informed of their assessment by the university. Applications should be sent electronically via the link "Apply now". The faculty expects applicants to read the information "How to apply for a position at SDU" before applying. Please note that the application documents should be in pdf-format and attached as three documents: motivation letter, CV and the remaining documents. We recommend that as an international applicant you take the time to visit Work in Denmark where you will find information and facts about moving to, working and living in Denmark, as well as the International Staff Office at SDU.

Responsibilities

The Ph.D. position focuses on biopharmaceutical investigations of long acting injectable suspensions, emphasizing formulation characterization and performance manipulation. The project aims to understand the biopharmaceutical performance of LAI suspensions through systematic investigation and data generation.