- Merck & Co. (Durham, NC)
- …with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable ... and patients on time, every time, across the globe. The Senior Maintenance Technician is responsible for providing equipment troubleshooting and maintenance… more
- Merck & Co. (Rahway, NJ)
- …the benefit of patients and global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), ... Python Programming for SDTM Conversions.Demonstrated success in the assurance of deliverable quality and process compliance .Excels in technical writing, able to… more
- Merck & Co. (Durham, NC)
- …striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, ... Job DescriptionJoin our dynamic Engineering, Maintenance, & Utility Department as a Senior Specialist, where you will play a crucial role in enhancing asset… more
- Merck & Co. (Rahway, NJ)
- …your leadership, technical skills, and scientific acumen as part of a global , cross-functional team . - Job Responsibilities - Responsible for leading specific ... Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of trial conduct. Providing… more
- Twist BioScience (South San Francisco, CA)
- …analytics, and data visualization capabilities to support operational decision-making and quality reviews. Compliance & Validation: Ensure our custom MES ... Sr . Director, Manufacturing Execution System (MES) (Hybrid in...our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well ... leadership development initiatives, drive adherence to established goals while ensuring compliance with policies and regulations, and partner with teams to promote… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and ... in compliance with cGMP and regulatory filings. Perform independent quality review and approval of batch records, testing data, and related documents… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to enable compliance with QMS process requirements across NNI and global as applicable Proactively identifies risks/ quality drift in external vendor and ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enable compliance with Deviation process requirements across NNI and global as applicable Develops and executes regular surveillance, follow-up, and reporting ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Merck & Co. (Rahway, NJ)
- …high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics and global PK/PD modeling ... being completed by stakeholders to facilitate an increase in efficiency and compliance for statistical/modeling analyses. -The senior programmer will also write… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily ... will require routine interaction with Partner Groups such as GES ( Global Engineering Services), Facilities Management (FM/GWES) and Original Equipment Manufacturers… more
- Merck & Co. (Rahway, NJ)
- …in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders ... market authorization, execute of post marketing commitments and meet compliance obligations.Qualifications and Skills:Required: Global Regulatory experience required… more
- Merck & Co. (South San Francisco, CA)
- …Metabolism, and Bioanalytics (PDMB) department of Research Laboratories is seeking a Senior Scientist specializing in AI/ML to support efforts in transforming the ... focused on bringing AI/ML approaches to bear to improve the speed and quality of decision-making in drug discovery and development. PDMB aims to leverage Generative… more
- Merck & Co. (North Wales, PA)
- …leadership, technical skills, and scientific acumen as part of a global , cross functional team.Job ResponsibilitiesResponsible for leading specific aspects of ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsibilities:Provide high quality statistical programming deliverables for global stakeholders in Early Development Statistics and PK/PD ... the development of programming standards to enable efficient and high- quality production of programming deliverables.Educational requirement:Must have a Master's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent, ... cutting-edge AI/GenAI technologies and developing AI/GenAI products to deliver high quality insights with speed and efficiency Promotes a culture of creativity… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) ... through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our biologics capabilities in… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all ... the execution of all aspects of end-to-end clinical trials with the utmost compliance and quality consistent with Good Clinical Practice (GCP). This individual… more
- Merck & Co. (Rahway, NJ)
- …of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities :Develops, coordinates, and provides biostatistical support for ... design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.Collaborates with the statistical programming staff to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
