Group Leader, Product Development

Catalent • Morrisville, NC

2d • Onsite

About The Position

Group Leader, Product Development Position Summary: Work Schedule: Monday - Friday, 8:00am to 5:00pm 100% on-site The Morrisville (MSV) facility is Catalent’s center of excellence for nasal product development and manufacturing, providing end‑to‑end services from early formulation through clinical and commercial production. The site offers comprehensive nasal development capabilities, including analytical support, device selection, spray characterization, and both clinical and commercial scale for unit‑dose, bi‑dose, and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization, method services and analytical testing. The Group Leader oversees a team of scientists engaged in early-phase product development of nasal and orally inhaled drug products. This role ensures technical excellence in formulation, analytical characterization, and early phase process development for feasibility and Phase I/II programs, while maintaining compliance with cGMP and site safety standards. The Group Leader acts as a key technical and operational leader, driving innovation, capability building, and efficiency in early-stage development.

Requirements

• Must have Ph. D in Pharmaceutics, Chemistry, Chemical Engineering, or related field with 2 years of industry experience OR Must have Master’s Degree in Pharmaceutics, Chemistry, Chemical Engineering, or related field with 4-7 years of industry experience OR Must have Bachelor’s Degree in Pharmaceutics, Chemistry, Chemical Engineering, or related field with 8-10+ years of industry experience
• Strong knowledge of cGMP, ICH guidelines, device standards, and early‑phase clinical development requirements is required
• Demonstrated leadership skills, including mentoring, performance management, and fostering team development is required

Nice To Haves

• Experience with inhalation/nasal injectable product development is preferred
• Deep technical expertise in formulation and analytical characterization of inhalation/nasal drug products (e.g., spray pattern, plume geometry, APSD, delivered dose) is preferred

Responsibilities

• Lead development of formulations and processes for nasal sprays, dry powder inhalers, and nebulized products in early-phase programs
• Oversee analytical method development and execution (e.g., spray pattern, plume geometry, APSD, delivered dose)
• Ensure robust documentation and data integrity for feasibility and clinical batch support
• Supervise and mentor scientists and technicians; set objectives, conduct performance reviews, and foster professional growth
• Manage lab scheduling, resource allocation, and workflow to meet project timelines
• Other duties as assigned

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
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!
• Catalent offers rewarding opportunities to further your career!
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree