Principal Scientist – Solubility Enhancement Technologies

About the role

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.

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

• A 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

• 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 programs
• 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 now through the Ardena Careers website at careers.ardena.com.