Manager, Manufacturing Science & Technology

Manager Manufacturing Science & Technology

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.

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 support CAPA development using structured problemsolving tools (e.g. FMEA Fishbone DOE).
• Other duties as assigned

The Candidate:

• Requires Masters Degree in Biochemistry Chemical Engineering Bioengineering or related technical field with 5 years of GMP pharmaceutical manufacturing experience OR
• Bachelors Degree in Biochemistry Chemical Engineering Bioengineering or related technical field 7 years of GMP pharmaceutical manufacturing experience
• Experience supporting formulation or nonsterile fill/finish operations in a GMP environment is required
• Familiarity with cGMP regulations for nonsterile liquid products and basic validation/qualification principles is required
• 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

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.

If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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