Senior Manager, Product Development

CatalentDurham, NC
1dOnsite

About The Position

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 Senior Manager, Product Development leads cross functional scientific and operational activities for the end-to-end development of orally inhaled and nasal drug products, ensuring technical excellence in formulation, analytical development, device/combination product integration, and process development while meeting client, regulatory, and quality expectations. This leader sets development strategy and control frameworks, ensuring plans are scientifically sound, phase appropriate, and rigorously executed. As a highly client facing role, it requires strong communication skills, the ability to translate complex science, and influence decision making. The Senior Manager also oversees resource planning, portfolio delivery, financial stewardship, and team development, fostering a culture of accountability, innovation, compliance, and operational excellence.

Requirements

  • Must have Master’s Degree or Ph.D. Degree in Pharmaceutics, Chemistry, Biochemistry, Chemical Engineering, or a related technical field, with at least 8 years of experience in pharmaceutical drug product development
  • Must have 4+ years of experience in a leadership role and developing high performing teams
  • Progressive pharmaceutical development experience, with significant time spent in OINDP (nasal sprays, DPIs, nebulized products, or combination products) is required
  • Proven success leading cross‑functional scientific teams in formulation, analytical development, device/combination product integration, and process development is required
  • Experience serving as a client‑facing technical lead, including communication of complex scientific concepts and influencing program strategy is required
  • Advanced understanding of regulatory expectations (FDA, ICH, USP), validation strategies, and data integrity requirements is required

Responsibilities

  • Lead end to end development of orally inhaled and nasal drug products, including sprays, DPIs, nebulized products, and emerging platforms
  • Provide technical leadership across formulation, analytical development, device/combination product integration, and process development
  • Develop, mentor, and lead scientific staff while fostering accountability, innovation, compliance, and operational excellence
  • Establish development strategy and control frameworks to ensure scientifically sound, phase appropriate, and compliant plans
  • Serve as the primary client facing technical lead, translating complex science and influencing decisions
  • Manage resources, portfolio workload, and financial stewardship to ensure efficient and timely delivery coordinating cross functional program execution across Formulation, Analytical, MS&T, Manufacturing, Quality, Regulatory, and Project Management
  • 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!
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