- Merck & Co. (Rahway, NJ)
- …in support of critical activities such as stability studies, drug product filling process validation , combination product final assembly process ... applying knowledge in drug and device product development, such as manufacturing process development and validation , design control, risk management, material… more
- Repligen (Waltham, MA)
- …drives progress. Join us!About the RoleRepligen is seeking a hands-on, strategic Director of IT & OT Infrastructure to lead the design, implementation, and ... and documentation standards.Drive GxP-compliant infrastructure planning, capacity management, and validation practices.Vendor, MSP & Budget ManagementManage MSPs, vendors, and… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Executive Director of Metabolism & Obesity will be responsible for overseeing and facilitating the research in metabolic diseases & obesity and ... and retain a talented team that delivers on target identification & validation and advances CMD pipeline.Education Requirement:PhD, MD, or MD/PhD degree in metabolic… more
- Insmed Incorporated (NJ)
- …and develop mitigation strategies CSV Program Oversight: Oversee the CSV team, validation strategy and continuous process improvementEnsure compliance with GxP ... to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage cross-functional teams and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …success. He/she is responsible to ensure their direct reports are properly trained, following process and SOPs. The Director will ensure the Senior Director , ... measures in place to course correct where needed. The Director will be accountable to support SDL and employee...are responsible to support improving GCO capabilities such as process improvements and support of additional guidance, tools, etc.… more
- Merck & Co. (Rahway, NJ)
- … process , and equipment, as well as qualification and validation .Demonstrated experience in a leadership role; managing technical teams supporting packaging ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...Centers of Excellence including technical guidance to component or process changes, supporting tech transfers and investigations.- Develop and… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Associate Director , Programming provides technical leadership and ensures adequate programming support for ... requirements, corporate and departmental SOPs and Work Instructions Leads process improvement initiatives Provides technical guidance to Insmed programmers,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- …in design controls, risk analysis, control strategies, design verification testing, and process validation , with a strong understanding of quality management ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role within the Device Development and Technology Organization. Thisposition is… more
- Insmed Incorporated (NJ)
- …compliance.Actively represent QA in technical development activities, including process development, method validation /transfer, formulation work, and ... of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for...activities.Support investigations and root cause analysis of product or process issues related to clinical manufacturing.Drive Quality input into… more
- Repligen (Rancho Dominguez, CA)
- …growing Quality team. You will play a key role in oversight of validation activities, management of changes, and investigations/root cause analysis. This is an ... Rancho Dominguez, CA site and will report to the Sr. Director of Quality.ResponsibilitiesUse/application of investigative tools to perform investigations and root… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Sunshine data and assisting in any needed state reporting data aggregation and validation . Serves as a key data validation expert on Government Accountability ... data in the analytics environment. Relationships Reports to the Director , Government Accountability. Works regularly with other compliance staff and functional… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director HVAC : The HVAC Associate Director is responsible for leading and developing a team that supports HVAC operations and system ... candidate will have strong technical expertise in HVAC design, maintenance, and validation within a highly regulated environment, combined with leadership skills to… more
- Insmed Incorporated (San Diego, CA)
- …what's possible for patients with serious diseases. Reporting to the Associate Director , Quality Control, you'll be involved in transfer of method from Analytical ... Control Senior Research Associate will author and execute phase appropriate qualification/ validation protocols and reports of QC methods to support product release,… more
- Insmed Incorporated (NJ)
- …possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for the publishing, management, and ... document authoring, review, approval, and publishing workflows.Conduct technical checks ( validation , bookmarking, hyperlinking) to ensure submissions pass regulatory agency… more
- Insmed Incorporated (NJ)
- …patients with serious diseases. In this role, you'll be reporting to the Director , Procurement Operations & SRM.The Insmed Summer Internship Program is designed to ... to support Insmed's Procure-to-Pay (P2P) transformation by assisting with data integrity, process analysis, and system readiness efforts as we prepare for the… more
- Insmed Incorporated (NJ)
- … process workflows and functional documentationCreate user stories and highlight process gapsSupport testing and validation of user stories and business ... what's possible for patients with serious diseases. Reporting to the Director , Commercial Applications, you'll contribute to the documentation and optimization of… more
- Merck & Co. (Rahway, NJ)
- …Responsibilities include, but are not limited to: Work closely with the group Director to shape and execute strategy for biological characterization in all stages of ... expertise in interpretation of characterization data in context of broader process and product development, critical reagents characterization and overall analytical… more
- SMBC (Jersey City, NJ)
- …its employees. **JOB SUMMARY:** Reporting to the Head of Model Risk, the Risk Model Validation Director plays an active role in the implementation of Model Risk ... the Combined US Operations of SMFG by performing independent validation and review of Stress Testing Models. **SCOPE:** As...about their specific hybrid work schedule during their interview process . Hybrid work may not be permitted for certain… more
