Principal Scientist - Solubility Enhancement Technologies

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] Ardena provides integrated services spanning drug substance development, drug product formulation, GMP manufacturing, bioanalytical services, clinical logistics, fill and finish, and CMC regulatory support. Job Overview Position: Principal Scientist – Solubility Enhancement Technologies Department: Product Development Location: Somerset (US) Role Description: 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. Key Responsibilities 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 organise assigned work across multiple concurrent projects, prioritising 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 analytical sections of regulatory submissions. Publish or present research findings internally and externally to advance scientific knowledge and Ardena’s profile. Position Requirements PhD in Chemistry, Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a closely related discipline is preferred. Candidates holding an MS or BS in a relevant field will be considered with the requisite years of experience outlined below. Experience PhD: minimum 5 years | MS: minimum 10 years | BS: minimum 12 years of experience in formulation development of prescription oral solid dosage forms. At least 3 years of hands‑on experience in ASD development is required, with demonstrated proficiency in hot melt extrusion (HME), spray drying, or both. Experience with both platforms is strongly preferred. Experience with twin‑screw melt granulation, twin‑screw wet granulation, and/or process analytical technology (PAT) is preferred. Hands‑on proficiency with DSC, TGA, XRPD, and hot‑stage microscopy is preferred. Knowledge & Skills A strong foundation in scientific principles relevant to pharmaceutical development is required, including organic chemistry, polymer chemistry, solid‑state chemistry, and pharmaceutics. Familiarity with common pharmaceutical processing techniques (tablets, capsules, modified‑release dosage forms) and proficiency in Microsoft Office (Word, Excel, PowerPoint) are expected. Hands‑on expertise in the following solubility enhancement technologies is required or strongly preferred: ASD by hot melt extrusion (HME) — required ASD by spray drying — required Nanosuspension technologies — preferred What Ardena Offers Ardena is a science‑driven and people‑focused employer. Working at Ardena means contributing to pharmaceutical projects that support the availability, safety, and quality of medicines for patients worldwide. Ardena offers an international working environment where employees are encouraged to develop their expertise, take ownership, and grow their careers across functions and locations. Benefits and perks at Ardena include Competitive salary and tailored benefits package (adjusted per role and location) Flexible working arrangements and paid annual leave (where applicable, depending on role and site) International and collaborative work environment across European and US sites Access to professional development and training programmes Meaningful work on pharmaceutical development projects that advance patient health A values‑driven culture guided by Ardena’s CARE principles: Communicative, Accountable, Reliable, and Excellent How to Apply Ready to advance your career in pharmaceutical development? Apply via the Ardena Careers website: careers.ardena.com #J-18808-Ljbffr