Manager, Manufacturing Science & Technology

Catalent • Durham, NC

1d • Onsite

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. This role provides technical support for process performance, troubleshooting, technology transfer, and continuous improvement activities. The Manager collaborates closely with Manufacturing, Quality, and Development to maintain product quality, ensure compliance, and drive operational efficiency.

Requirements

• Requires Master’s Degree in Biochemistry, Chemical Engineering, Bioengineering, or related technical field with 5+ years of GMP pharmaceutical manufacturing experience OR
• Bachelor’s Degree in Biochemistry, Chemical Engineering, Bioengineering, or related technical field 7+ years of GMP pharmaceutical manufacturing experience
• Experience supporting formulation or non‑sterile fill/finish operations in a GMP environment is required
• Familiarity with cGMP regulations for non‑sterile liquid products and basic validation/qualification principles is required

Nice To Haves

• Working knowledge of 21 CFR Part 4 and 21 CFR Part 820 expectations for nasal spray combination products is preferred
• Experience with DOE/statistical tools and analytical method development is preferred

Responsibilities

• Plan and execute defined experimental studies, process evaluations, and equipment qualification activities, including review technical reports, protocols, and data packages to ensure accuracy and completeness
• Maintain process, analytical, and raw material knowledge needed to support ongoing production and investigations
• Provide technical support for formulation, compounding, fill/finish, assembly, packaging, and labeling operations to ensure compliant and reliable manufacturing
• Assist with technology transfer activities for clinical and commercial manufacturing, including coordination with internal and external partners to ensure production schedules maintained and processes are run reliably and compliantly.
• Monitor critical quality attributes (CQAs) and critical process parameters (CPPs) to detect trends and recommend corrective actions
• Lead investigations to determine root cause and support CAPA development using structured problem‑solving tools (e.g., FMEA, Fishbone, DOE).
• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager