- Repligen (Waltham, MA)
- …a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or ... and infrastructure changes to ensure "controls by design."Maintain ITGC narratives, process flows, and risk/control matrices.Identify and drive process … more
- Cipla (Hauppauge, NY)
- …to end business processes to have the capability to propose system changes, process transformations in line with the evolving business requirements. SAP Support for ... Production , Warehouse and Quality Handling Audit Trails, CSV activities...solution (if so to what extent) vs Standardizing/Transforming business process Follow best practices Scaling Global solution to other… more
- Repligen (Waltham, MA)
- …a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or ... excellence. This role ensures commercial effectiveness through strategic leadership, process optimization, and the integration of advanced technologies, including… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug ... material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with… more
- SOFIE (Totowa, NJ)
- …212). Essential Duties and Responsibilities Develop protocols for the production and analysis of clinical-grade radiopharmaceuticals, validate these methodologies ... against quality requirements, and implement them for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards. o It is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. They will also oversee processes and standards to maintain and ... specified requirements.Provide technical expertise in the Technical Operations group, own the process knowledge of the cell and gene therapy manufacturing process… more
- Aptyx (Charlotte, NC)
- …for inspection, including organization and cleaning of station Audit samples of in- process components, sub-assemblies, and final product to ensure they meet customer ... Manual and all applicable work instructions Inform supervisor and/or Production Line Supervisor of issues or unanticipated non-conformances. Advise supervisor… more
- Tris Pharma (Monmouth Junction, NJ)
- …Agency (DEA) requirements are being followed with respect to the production of controlled substances Reports and investigates any deviations from processes ... or procedures Maintains a presence on the production floor at all times; Trains new employees and...work experience must include multiple aspects of the manufacturing process in a pharmaceutical or biotechnology cGMP regulated environment… more
- Repligen (Waltham, MA)
- …a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or ... and reports for management reviewContribute to special projects and process improvement initiatives as neededQualificationsBachelor's degree preferred, but equivalent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP ... groups to establish a strong, compliant CQV program to enable robust production , testing and release of product to patients.Key Responsibilities Executes the… more
