- Merck & Co. (Rahway, NJ)
- …Focus, Operational Strategies, Outsourcing, Process Improvements, Production Scheduling, Project Management Planning, Quality Compliance, Regulatory ... eight (8) years combined experiences in commercial/business and manufacturing (operations, project management, or quality , technology, supply chain etc.)… more
- Merck & Co. (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance, and R&D. The Director will serve as the ... Sr. Director , Manufacturing Execution System (MES) (Hybrid in South...with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Director , HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle ... internal business partners and external agenciesActively participate in cross-functional project teams involving Marketing, Sales, Managed Markets/Market Access, Legal,… more
- Formation Bio (New York, NY)
- …role in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and ... Collaboration & External Partnerships Partner closely with analytical development, manufacturing, quality , and regulatory teams to ensure seamless execution of… more
- Eisai, Inc (Exton, PA)
- …well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics ... supporting technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing scientific… more
- Merck & Co. (Durham, NC)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision ... within R&D. Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable… more
- Twist BioScience (South San Francisco, CA)
- …to lead our global marketing efforts and drive sustainable growth. The Sr Director , Marketing is responsible for leading all aspects of Twist's global marketing ... activities related to launching new products; and interfacing with customers. The Sr Director , Marketing also will lead growth marketing, social media and trade show… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cutting-edge AI/GenAI technologies and developing AI/GenAI products to deliver high quality insights with speed and efficiency Promotes a culture of creativity ... IT, Ethics and Compliance, Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues. Externally, this role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality ... while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to… more
- Merck & Co. (Rahway, NJ)
- …Leadership, Plant Maintenance, Preventative Maintenance Programs, Process Control Systems, Project Management, Regulatory Compliance, Regulatory Requirements ... Job DescriptionAssociate Director HVAC : The HVAC Associate Director...Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain optimal environmental conditions… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.The… more
- Merck & Co. (North Wales, PA)
- …data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the development 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. (Durham, NC)
- …Process Optimization, Process Troubleshooting, Production Operations, Production Support, Project Management, Regulatory Compliance, Teamwork, Training and ... opportunity for a Specialist to join the operations team supporting a capital project critical to Human Health at our facilities in Durham, North Carolina. This… more
- Merck & Co. (Rahway, NJ)
- …data/medical protocol deviations in collaborations with the Clinical Director . Other responsibilities include: Collaborating cross-functionally in the development ... Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of trial conduct. Providing… more
