Senior Manager, MS&T

Senior Manager Manufacturing Science & Technology Drug Product

Position Summary

• 100% on-site

Catalent Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop manufacture and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma biotech and consumer health customers supporting product development launch and full life-cycle supply. With time-tested experience in development sciences delivery technologies and multi-modality manufacturing Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Senior Manager Manufacturing Science and Technology (MS&T) is responsible for leading the Manufacturing Science and Technology organization at the Morrisville site to ensure consistent and reliable production of liquid non-sterile drug products. This role involves technical leadership for the lifecycle management commercialization and continuous improvement oversight of process improvements regulatory compliance and technical leadership in the production environment. The Senior Manager leads process understanding troubleshooting technology transfer and post-approval change management to ensure consistent product quality regulatory compliance and operational excellence.

The role:

• Monitor and improve manufacturing processes including data and reports supporting regulatory compliance of drug products as they are processed through formulation and non-sterile fill/finish for liquid nasal products.
• Define and direct staff activities to plan execute and document experiments studies and manufacturing processes that qualify key equipment raw materials and processes for clinical and commercial production.
• Provide ownership and management of process analytical and characterization knowledge related to drug product production and the raw materials required.
• Build and maintain a high-performing staff of engineers and scientists to support ongoing production and process transfers.
• Technical ownership of drug product manufacturing process (formulation compounding fill/finish assembly packaging and labeling).
• Lead technology transfer activities from development to clinical and commercial manufacturing including internal sites and CMOs/CDMO

The candidate:

• M.S. degree in biochemistry chemical engineering bioengineering or a related technical field with at least 8 years of experience in pharmaceutical manufacturing; or a B.S. degree with 10 years of experience in the same field.
• Excellent oral and written communication skills.
• Experience in senior laboratory or operational roles within a biopharmaceutical GMP manufacturing environment including experience with formulation and non-sterile fill/finish activities.
• Familiarity with global cGMP manufacturing regulations for non-sterile liquid products and associated validation/qualification requirements.
• Working knowledge of 21 CFR Part 4 (Combination Product cGMPs) and 21 CFR Part 820 FDA expectations for nasal spray combination products.
• Proven ability to effectively lead and participate in teams.
• May require up to 10% travel.

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO 8 Paid Holidays
• Dynamic fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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