Nature and Scope This entry level position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. They ensure aseptic and sanitary conditions are maintained where required, that appropriate manufacturing

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Overall Portfolio Management including launch strategy, pricing and contracting strategy, inputs on forecasting and demand planning, monitoring of gross and contribution margins, seeking out efficiencies where feasible. Development and mo

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Assist in continual improvements and facilitation for onboarding for onsite and offsite employees. Facilitation of Training Programs throughout the company including but limited to Data Integrity Trainings, Post Orientation, Professional

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Responsible for the implementation, maintenance, administration and communication of American Regent's health & welfare benefit plans, work life balance policies, and retirement program. Responsible for collaborating with leadership on th

This Medical Director, Pharmacovigilance position will directly report to the Senior Medical Director, Head of Pharmacovigilance. This position is responsible for the accurate and timely reporting of product safety information to the organization and regulatory authorities world wide as assigned by the Head of Pharmacovigilance. Provide medical support to the PV team for

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Lead deviation/investigation activities involving production batch records, and support release of product for shipment. Oversee Functional Areas and site QA investigations to ensure they are complete. Lead Investigator personnel and othe

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Builds and develops enduring trusted partnerships through scientific engagement and exchange with KOL's and health care providers (HCPs) at the national, regional and local level Regularly collects and interprets medical insights and feed

Receiving Functions Verify incoming shipments against Bill of Ladings, and Purchase orders for correct items, counts and contents. Receive incoming inventory and commodities directly in the AS400 computer system or by the use of scanning guns. Put away received inventory items in proper storage locations. Deliver received non inventory materials to end user community. Seg

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Perform manufacturing and development activities within a cleanroom environment. Cleans and stores manufacturing equipment and areas as required to support manufacturing activities. Sanitization/disinfection of components, materials and p

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements. Manage assigned daily workload to meet requirements and perfor

Nature and scope Working as part of a multi disciplinary team, the Process Engineer must possess the ability to manage multiple tasks simultaneously, manage projects and project timelines, and create project specific documentation, drive project procurement, implementation, and project closure in an FDA regulated environment. This position will be required to develop proc

The Validation Technician is responsible for validation equipment preparation, protocol execution and final report generation as directed. This position will be primarily responsible for the execution of protocols associated with the installation, operation qualification and requalification of equipment, and utilities used in the analysis and manufacture of sterile pharma