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The QA/RA Compliance Specialist ensures compliance with pharmaceutical regulations by managing change controls, preparing regulatory filings, and collaborating with various departments. Responsibilities include assisting in SOP development, supporting audits, and liaising with customers.
The Associate Scientist engages in pharmaceutical development and clinical manufacturing projects, overseeing tasks like formulation, data interpretation, and documentation while ensuring timely execution of responsibilities and ongoing communication with internal teams and clients.
The QA Product Manager acts as a customer liaison, focuses on quality and compliance, and oversees Quality Assurance for technical documents. Responsibilities include generating quality metrics, providing QA technical recommendations, supporting audits, and ensuring compliance with cGMP requirements.
The Development Scientist II is responsible for pharmaceutical development and clinical manufacturing project activities, including formulation and process development, GMP compliance, budget planning, customer interaction, and documentation writing. The role involves assisting with batch manufacturing and problem-solving in formulation processes while ensuring accuracy and compliance with guidelines.
The Global Lean Leader guides Catalent manufacturing sites worldwide in adopting lean practices. Responsibilities include training, coaching, and facilitating continuous improvement initiatives using Lean Six Sigma methods. This role requires a deep understanding of change management and analytics to enhance operational efficiency and support performance metrics across the organization.
The Senior Manager, QC oversees microbiological and environmental monitoring activities, ensuring routine testing of drug products and substances align with quality standards. Responsibilities include managing a team, collaborating with stakeholders, executing analytical testing, and revenue reporting.
The Master Scheduler oversees the development and maintenance of the Master Schedule and short-term production schedules for Catalent's Commercial and Development products. They partner with various teams to translate requirements into schedule, monitor daily operations, and facilitate production capacity reviews, ensuring alignment across departments and timely delivery of products.
The Senior Associate Scientist will conduct experiments, perform analytical product testing, and ensure compliance with regulatory standards. Responsibilities include testing stability samples, conducting laboratory investigations, and data analysis, all while adhering to SOPs and cGMPs.
The Manager, Human Resources at Catalent Gene Therapy in Harmans, MD is responsible for developing and implementing HR policies and programs, supporting staffing, employee relations, compensation, benefits, training, and organizational development. They oversee compliance with company policies and regulations, provide HR counsel and training, and work on talent management and cultural change initiatives.
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