Catalent
Pharmaceutical
Manager,ManufacturingScience&Technology
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“Manager, Manufacturing Science & Technology at Catalent. Skills: Manufacturing Science & Technology, process performance, troubleshooting, technology transfer, continuous improvement, formulation, non‑sterile fill/finish operations. Plan and execute defined experimental studies, process evaluations, and equipment qualification activities. Maintain process, analytical, and raw material knowledge needed to support ongoing production and investigations”
What You'll Achieve.
maintain product quality; ensure compliance; drive operational efficiency; ensure production schedules maintained; processes are run reliably and compliantly; detect trends and recommend corrective actions
Industry & Context.
troubleshooting; investigations; root cause analysis; CAPA development; structured problem‑solving tools
100% on-site
What They're Looking For.
Must Have
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 Have
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
What You'll Do.
Plan and execute defined experimental studies
and equipment qualification activities
and raw material knowledge needed to support ongoing production and investigations
Provide technical support for formulation
and labeling operations
Assist with technology transfer activities for clinical and commercial manufacturing
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
How You'll Work.
Team & Collaboration
collaborates closely with Manufacturing, Quality, and Development; coordination with internal and external partners
Process & Methodology
Plan and execute defined experimental studies, assist with technology transfer activities
Full Job Description
**Manager, Manufacturing Science & Technology** **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. 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. **The Role:** * 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
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