Principal Scientist – Solubility Enhancement Technologies

Overview

About Ardena Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market. The Ardena Group operates from five sites across Europe and the United States, employing more than 750 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain).

Ardena US facility is based in Somerset, New Jersey.

For the Ardena Business Unit based in Somerset (US), we are looking for a [Job Title].

Title: Principal Scientist – Solubility Enhancement Technologies

Department: Product Development

Location: Somerset (US)

The Principal Scientist – Solubility Enhancement Technologies leads formulation and process development for oral solid dosage forms, with a primary focus on hot melt extrusion (HME), spray drying, and amorphous solid dispersion (ASD) technologies. Working across the full development continuum from preclinical through commercial, this role serves as a key technical contributor and scientific expert within Ardena’s CDMO environment. The successful candidate will bring deep expertise across multiple solubility enhancement platforms, the ability to plan and organise their own work effectively, a client-service orientation, and a commitment to quality and regulatory compliance.

• Lead the development of amorphous solid dispersions (ASD) and solubility-enhanced oral dosage forms using hot melt extrusion (HME) and spray drying as the primary technology platforms, from preclinical concept through clinical and commercial formulation.
• Apply expertise in solid oral dosage form development — encompassing formulation design, process development, scale-up, and technology transfer — across preclinical, clinical, and commercial stages.
• Define pilot plant batch manufacturing requirements, oversee study execution, and provide technical consultation during clinical and commercial batch manufacture.
• Collaborate with the preformulation team to characterize materials using DSC, TGA, XRPD, SEM, and hot-stage microscopy; interpret data and apply findings to formulation strategy.
• Author high-quality GDP-compliant technical documents including development reports, technical specifications, project risk assessments, and regulatory CMC submissions in accordance with applicable guidance and site SOPs.
• Design and interpret experiments using statistical analysis, design of experiments (DoE), and data visualization tools to support robust development decisions.
• Plan and organize assigned work across multiple concurrent projects, prioritizing effectively to meet scientific, regulatory, and client timelines.
• Develop formulation strategies and lifecycle plans that align with regulatory requirements and client objectives.
• Proactively acquire and apply new scientific principles and technologies with minimal direction.
• Ensure compliance with Health, Safety, and Environmental requirements; maintain current training records for all required procedures.
• Contribute to the training and mentoring of junior R&D personnel as required.
• Communicate scientific findings clearly and persuasively in written and verbal formats to both internal teams and external clients.
• Manage difficult client discussions constructively, guiding conversations toward acceptable resolutions.
• Enhance Ardena’s scientific visibility through publications, webinars, conference presentations, and symposia.
• Support departmental goals by delivering high-quality technical work and maintaining strong client relationships.
• Identify and recommend emerging technologies with potential application to Ardena’s solubility enhancement service offerings.

• Support Business Development activities as needed, including client calls, new customer meetings, and occasional travel to help secure new business.

• Understand the structure and content requirements of CMC regulatory filing packages; author and review formulation and…