Principal Scientist Preformulation Lead
Locations: Beerse, Belgium
Functions: Product Development
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Requisition ID: 1905721946W
Pharmaceutical Sciences is a department of Small Molecule Pharmaceutical Development (SMPD) within Discovery, Product Development and Supply (DPDS). Within the department resides the preformulation group, supporting Discovery, Active Product Ingredient Development, Drug Product Development, BioPharmaceutics, Analytical Development and others, to help understand the physicochemical properties of potential drug candidates, aid in compound selection, establish in depth understanding of the pharmaceutical formulations and aid in the definition of the pharmaceutical development trajectory.
In the Pharmaceutical Sciences department in Beerse-Belgium, there is currently a full-time opening for a Principal Scientist Preformulation Lead
* Effectively leading and managing the preformulation team to meet strategic objectives
* Preformulation labs (BE & SH): E2E preformulation activities for the entire small molecules development portfolio in support of all formulation platforms through in depth understanding of the compound physical properties (solubility, pKa, solid state,…).
* Full collaboration with BioPharmaceutics and Dissolution development by providing E2E in vitro support to understand in vivo behaviour of drug and drug product, this includes executing and developing new assays for all drug delivery systems in function of targeted PK profile and route of administration (in biorelevant or human media) and solubility experiments in different QC media.
* Full collaboration with Developability, providing support for assessment of NME readiness of different compounds.
* Bridge to Parenteral & Liquids group and Oral Solids Development, to translate physicochemical properties of new compounds into formulation advice and potential path forward for further development. Troubleshoot any fundamental formulation challenges with impact of the physicochemical properties of the compound.
* Seamless collaboration with the High Throughput experimentation lab to optimize workload of experiments in automated or manual way.
* Guiding subject matter experts in preformulation, which support the product portfolio, providing E2E portfolio insights and cross functional insights.
* Effectively and efficiently leading the labs to deliver outstanding operational performance with scientific excellence in line with current and future company strategic needs. Processes are optimized when needed. Proper recording of information, proper retaining of records and raw data; timely preparation of technical reports, manuscripts and other documents is ensured. Compliance with the GMP requirements and other legislations related to GMP activities in the lab environment and a safe working environment is ensured. Recommendations and justifications of investment into equipment and/or technologies essential to support development of the portfolio are made, while assuring alignment at a strategic level.
* Effective resource planning for the preformulation team with the right balance of internal and external resources. The job holder is responsible for strengthening and maintaining strategic partnerships with CRO's aligned with AD, DPD, API SM and DS.
* Innovation and managing knowledge to deliver on the current and future portfolio work with the multidisciplinary team of scientists to stay abreast of scientific developments and innovations, ensuring that pharmaceutical sciences has the capabilities to perform to world class standard in the area of preformulation through internal investments and partnering with external networks (academia, CRO's,..). These innovations could include nasal delivery through nebulization, nose to brain delivery, intratumor delivery,…Expand external scientific visibility for the team.
* The job holder is responsible for coaching, hiring, promotions, pay adjustments, performance appraisals, other people related decisions and talent development of the preformulation team. This means responsibility for leading and developing a high performing team, creating an increasing capability and depth of science.
* Degree in Sciences: Pharmaceutical, Chemistry (analytical/organic), Physics, or a related science or Degree in Engineering. Knowledge of physical chemistry is a must.
* 10+ years of industry experience
* Strong scientific interest and analytical mindset is a must
* Experience required in one or more of the following fields: Physicochemical characterization of therapeutic candidates, UPLC, API solubility/crystallization/polymorph/salt formation, spectroscopy, conventional and enabling formulations, physicochemical characterization of therapeutic candidates.
* Strong physical and analytical chemistry background preferred, understanding broad pharmaceutical product development picture is required including high level principles of preclinical and clinical development
* Highly motivated, with excellent organizational, interpersonal, communication, and collaborative skills
* Fluent English (both spoken and written), willing to learn basics of Dutch language.
* Good English scientific writing skills.
* This position will be based out of Beerse, Belgium and may require 5 to 10 % of travel.
Janssen Pharmaceutica N.V. (7555)