- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking AD, Site Supply Chain as part of the Supply Chain team based in Raritan, NJ. ... Role OverviewThe Site Supply Chain Lead will be part of the...critical components.Monitor inventory levels and implement best practices for safety stock and demand variability.Lead and perform future forecasting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for clinical trials and commercial operation in a controlled cGMP cleanroom environment . This position is responsible for quality and maintaining the highest ... activities for cGMP compliance through spot checks/internal audits.Collaborate with site personnel to provide guidance and determine immediate path forward… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility to support both clinical and commercial requirements in a sterile GMP environment . This role will serve as the business process owner for the Corrective ... Provide oversight to the CAPA program for the CAR-T manufacturing site .Oversee metrics, trending, and reporting of relevant quality systems records.Support CAPA… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to support both clinical and commercial requirements in a sterile GMP environment . This role will be responsible for managing change control activities throughout ... the lifecycle.Key ResponsibilitiesSupport and streamline the site change control process.Participate in change control process from initiation through… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to support both clinical and commercial requirements in a sterile GMP environment . This role will also provide oversight of technical, qualification, and validation ... and quality requirements for maintaining a compliant state for all site systems.Assist in the development of validation and qualification related policies,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and commissioning / qualification professionals.Ensure compliance with all applicable health , safety , environmental, and building regulations (OSHA, ADA, ... experience in engineering leadership roles, preferably in a Car-T / large-scale site and 24/7 environment .Strong knowledge of building systems (HVAC, electrical,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …plant. This individual will lead continuous improvement initiatives with various site functions to support of personalized cell therapy production through safe ... effective, holistic continuous improvement and problem solving program to improve safety , compliance, cost, process stability building quality and efficiency into… more
- Merck & Co. (Rahway, NJ)
- … Site S&E team, work collaboratively to ensure that compliant environmental, health , and safety (EHS) programs are developed and implemented within operating ... departments at the Rahway site . Integrates EHS programs into daily operations to assure...and addresses challenges.Primary ActivitiesWith a deep knowledge of environmental, health and safety regulations and their applicability,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Health Authority regulations, International Conference on Harmonization (ICH) guidelines ... and Solutions (MARS) team to drive and monitor progress. The SDL fosters an environment where the core study team maximizes their expertise and contribution to trial… more
- Merck & Co. (Rahway, NJ)
- …trained and practice safe operating procedures in support of requirements.Ensure compliance ( Safety , Health , Environmental, GxP (as applicable), DOT, Labor, HR, ... in HVAC design, maintenance, and validation within a highly regulated environment , combined with leadership skills to manage teams effectively.The Associate Director… more
- Merck & Co. (Rahway, NJ)
- …medical drugs and vaccines for the benefit of patients and global human health .The Senior Associate will provide administrative support to senior leaders in the ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
- Merck & Co. (Rahway, NJ)
- …and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate Director of Regulatory Submissions Archive Operations ... of regulatory submission types (eCTD, IND, NDA, ANDA) and Health Authority requirements. Knowledge of system development lifecycle, data/content administration… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports,… more
- Merck & Co. (Rahway, NJ)
- …of critical launches, the Global Trademark Development (GTD) team in Human Health (HH) Marketing drives, manages, and implements the end-to-end process for ... and business development assets of HH marketing in accordance with health authority and governmental trademark office requirements. The Associate Director will… more
- Merck & Co. (Rahway, NJ)
- …external manufacturing sites, process validation, second generation process development and health authority licensure. - You'll lead the charge in transforming our ... diverse teams to achieve program goals as One Team. Champion compliance and safety ; promote a culture of diversity, inclusion, and equity. Experience and aptitude to… more
- Merck & Co. (Rahway, NJ)
- …manufacturing sites, process validation, second generation process development and health authority licensure.-You'll be supporting the charge in transforming our ... diverse teams to achieve program goals as One Team. Champion compliance and safety ; promote a culture of diversity, inclusion, and equity. Experience and aptitude to… more
- Merck & Co. (Rahway, NJ)
- …researchers, designed to provide you with an academic focus in a commercial environment . With the resources, reach, and expertise of a large pharmaceutical company, ... solve complex process development challenges in an interdisciplinary, collaborative environment via invention, development, and application of cutting-edge tools.… more
- Merck & Co. (Rahway, NJ)
- …responsible for identifying new molecular entities and technologies for use in animal health from our Company Laboratories or from external partners such as human ... Process Chemistry, in vitro Pharmacology, Pharmacokinetics, Disease Models, Formulation Development, Safety & Toxicology).- The position will report directly to the… more
- Merck & Co. (Rahway, NJ)
- …subject matter expert technical support for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.- The Packaging ... for development of standard work to characterize the real-world distribution environment , and to translate that into distribution related characterization of… more
- Merck & Co. (Rahway, NJ)
- …and vaccines for the benefit of patients and global human health .This position provides high quality statistical programming deliverables for global stakeholders ... plus 3 years SAS programming experience in a clinical trial environment Department Required Skills and Experience: Excellent communication (oral, written) skills,… more
