Senior Manager, MS&T

Catalent Pharma Solutions•Morrisville, NC

33d•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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