Senior Scientist, Product Development

Position Summary:

Catalent Pharma Solutions in Morrisville, NC is hiring a Senior Scientist for the Product Development group. This person will serve as the primary subject matter expert (SME) and client liaison related to device related development activities supporting nasal and inhalation development programs. The Senior Scientist will plan, conduct, and supervise assignments involving the identification, assessment, and development of new scientific concepts and technologies relating to supporting the characterization and functional assessment of nasal and inhalation products. This person also reviews progress and evaluates results, plans and assigns personnel for projects or tasks, recommends changes in procedures, operates with substantial latitude for unreviewed action or decision, and reviews progress with management.

This is a full-time position: Monday – Friday, 8:00AM – 5:00PM.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Research Triangle Park (RTP) facility is home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.  

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role

• Review technical documents for accuracy, thoroughness, and regulatory compliance
• Responsible as technical development lead on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationship to grow the business
• Design experimental studies such as feasibility and reliability assessments to evaluate device performance and function for early and late phase programs
• Lead and mentor multi-disciplinary project team of internal scientists and engineers to meet technical milestones on appropriate timelines and provide technical feedback and recommendations at the project level
• Support statistical evaluation of product and process data
• Provide technical support to Operations by establishing the requirements for batch manufacturing and overseeing the execution of any required studies as well as leading risk assessments
• Represent Catalent and create expert content such as: posters, white papers, webinars & create relationships with academic collaborators
• Identify and support the introduction of new technologies to enhance product development capabilities at the site
• All other duties as assigned;

The Candidate

• Bachelors degree in physical, chemical, biological, engineering, or pharmaceutical science is required; Masters degree of PhD preferred
• With a Bachelors degree six or more years of formulation experience for combination drug products is required
• With a Masters degree four or more years of formulation experience for combination drug products is required
• With a PhD two or more years of formulation experience for combination drug products is required
• Experience conducting risk assessments using FMEA and FTA is required
• Hands on experience and knowledge with Design of Experiments (DoE) and experience statistical software packages (e.g. Minitab) is required
• Experience with drug-device combination products is required
• Knowledge of devices used for nasal delivery and oral inhalation and how their design and function support performance requirements is preferred
• Expertise with drug-device product evaluation such as droplet-size distribution, spray content uniformity, plume geometry, and spray pattern is preferred
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performan