Group Leader, Product Development

Group Leader Product Development

Position Summary:

• Work Schedule:Monday - Friday 8:00am to 5:00pm
• 100% on-site

The Morrisville (MSV) facility is Catalents center of excellence for nasal product development and manufacturing providing endtoend 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 unitdose bidose and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization methodservicesand 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 whilemaintainingcompliance 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.

The Role:

• 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; setobjectives conduct performance reviews and foster professional growth
• Manage lab scheduling resource allocation and workflow to meet project timelines
• Other duties as assigned

The Candidate:

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

Why you should join Catalent:

• 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 7000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. 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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer including disability and veterans.

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