Job OverviewPosition: Principal Scientist - Solubility Enhancement Technologies
Department: Product Development
Location: Somerset (US)
Role DescriptionThe 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 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 RequirementsA 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
How to ApplyReady to advance your career in pharmaceutical development? Apply now through the Ardena Careers website at careers.ardena.com.
Department Research & Development Locations Somerset (New Jersey, US) Remote status Hybrid
