Scientist II, Product Development

About the role

Catalent’s Morrisville, North Carolina (RTP) site is a global Center of Excellence for nasal product development and manufacturing, delivering end-to-end inhalation services from early formulation through clinical and commercial production. The site offers comprehensive capabilities including nasal formulation development and optimization, spray characterization, device selection and compatibility testing, and clinical-to-commercial scale filling and assembly for unit-dose, bi-dose, and multidose products. In addition to nasal therapies, the site supports dry powder inhaler (DPI) and liquid pulmonary product development, integrating analytical testing, process development, spray drying, and capsule-filling technologies. With multidisciplinary analytical and development teams working side by side, the Morrisville site plays a critical role in Catalent’s global inhalation network, enabling efficient, scientifically rigorous advancement of respiratory drug programs.

Responsibilities

• Design, execute, and support drug product development activities throughout the product lifecycle
• Work on formulation, method development and validation, troubleshooting, and analytical testing to support product development programs, including release and stability studies
• Act as a technical lead for one or more projects, managing assigned activities and timelines; contribute to project deliverables, milestones, and client communications; provide technical input into risk assessments and development strategies
• Author, review, and maintain technical documents such as protocols, reports, standard operating procedures, development reports, and product specifications, ensuring compliance with Good Manufacturing Practices, Good Documentation Practices, and data integrity requirements
• Identify opportunities to improve processes, methods, or technologies; support implementation of new technologies and development approaches; contribute to departmental efficiency and capability building
• Support technical training activities within the Inhalation Department

Requirements

Minimum Requirements:

• Ph.D. with no minimum experience required, or Master’s Degree with minimum 4 years of relevant experience, or Bachelor’s Degree with minimum 6 years of relevant experience
• Experience and knowledge of the fundamental principles of Good Manufacturing Practices, Good Documentation Practices, and Data Integrity
• Knowledge of formulation properties including drug potency, stability, pharmacokinetics, and drug-excipient interactions
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds
• May require the use of a respirator

Preferred Skills & Background

• Experience with spray testing for nasal and inhalation products
• Experience and knowledge with Design of Experiments and statistical software packages such as Minitab
• Knowledge of development for drug-device combination products for nasal and inhalation dosage forms

Benefits

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
Competitive paid time off plus 8 paid holidays
Medical, dental, and vision benefits effective day one of employment
Tuition reimbursement

Why You Should Join Catalent

Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.