- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based ... global MSAT organization. This individual will be responsible to support global process validation activities in support of the commercial Carvykti program both… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global regulatory ... development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical functions and will act… more
- ValSource, Inc. (Worcester, MA)
- …supervisor and Safety lead ensuring client Safety and Quality standards are upheld. Lead and oversee Execution phase for the Process Team with CQV team, ... projects. Strong working knowledge of GMP systems, equipment qualification, and process operations. Proven ability to lead teams, manage stakeholders,… more
- Merck & Co. (Rahway, NJ)
- …innovative technologies. Lead the design and execution of bench scale process development experiments to meet various project requirements, with the ultimate aim ... Job DescriptionThe Microbial Process Operations (MPO) Team is seeking a Senior...cross functional teams to address challenges throughout the entire lifecycle of enzyme manufacturing from discovery to commercial supply.… more
- Syner-G BioPharma Group (Boston, MA)
- …quality and regulatory requirements.Provide technical support for the product/ process lifecycle and related activities.Support client requirements to lead or ... the life sciences industry, supporting critical phases of the drug development lifecycle , from discovery and regulatory approval to technology transfer and the… more
- Aequor (Aliquippa, PA)
- …Prepare for and support internal and external regulatory inspections and audits. Lead the development, revision, and lifecycle management of Standard Operating ... materials receipt tracker solution to provide real-time visibility of receipt lifecycle status and quality workflow stages. Develop, maintain, and monitor incoming… more
- Eisai, Inc (Nutley, NJ)
- …East, and Africa.The Director will manage regulatory submissions, registrations, and lifecycle management activities for new and existing products in these regions, ... and implement regulatory strategies for market entry, product registrations, and lifecycle management for new and existing products across growth markets, including… more
- Merck & Co. (Rahway, NJ)
- …and communication skills, empathy, and attention to detail.- This role will lead various processes in multiple benefit programs, including our Company's Puerto Rico ... plans for Union and Non-Union employees. Responsibilities Benefit Plan Lead Lead ongoing administration and special projects...& benefits programs at critical moments in their career lifecycle Review and research employee and retiree issues to… more
- Insmed Incorporated (NJ)
- …the full lifecycle of the medical materials review and approval process . You will ensure efficient coordination of MRC activities, compliance with company ... the quality and integrity of all reviewed materials. By driving process excellence, governance, and cross-functional collaboration, you will support timely,… more
- Merck & Co. (Boston, MA)
- Job DescriptionWe are seeking an experienced Technical Product Manager to lead pharmaceutical process and meth od development data product portfolio. This unique ... understanding of biopharma research, hands-on experience with- domains of pharmaceutical process , method development and tech transfer for commercial manufacturing… more
- Merck & Co. (Rahway, NJ)
- …registration, and planning teams to maintain alignment across the regulatory lifecycle . Electronic and Paper Archive Management Oversee the central archive team, ... ANDA) and Health Authority requirements. Knowledge of system development lifecycle , data/content administration concepts, and capabilities applying technology within… more
- Merck & Co. (Rahway, NJ)
- …agencies, and health systems globally. The ability to successfully participate in and lead cross-functional teams is a critical part of this role. The Executive ... is expected to contribute to product development and marketing strategies throughout the lifecycle to ensure that product value is defined and developed to achieve… more
- Merck & Co. (Rahway, NJ)
- …Innovation, Life Science, Management Process , Manufacturing Scale-Up, Process Improvements, Product Commercialization, Product Lifecycle , Product Management, ... and information to others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in the best interest of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position We are seeking a highly organized and detail-oriented Business Process Oversight Manager to oversee all aspects of Good Practice (GxP) documentation ... ideal candidate will have a strong background in documentation management, process oversight, and regulatory compliance within the pharmaceutical or biotechnology… more
- Formation Bio (New York, NY)
- …milestones until steady-state ownership is established.Key ResponsibilitiesDiligence Program Management Lead and manage the full diligence process from ... (BD) and cross-functional teams across the end-to-end asset diligence lifecycle -from initial screen through confirmatory diligence and integration. This role… more
- Usaa (Plano, TX)
- …and presenting potential unmitigated risks to the business throughout the project lifecycle . A foundation in accounting principles and critical thinking skills are ... Communicates results of risk and compliance work to governance committees, business process owners and various levels of leadership. Implements new risk policies,… more
- Formation Bio (New York, NY)
- …IP law firms Navigate formulation findings, method of use patents, lifecycle management strategies, process -related discoveries and labeling-related IP issues ... enhance, and maximize the value of these innovations throughout their entire lifecycle - from initial diligence through clinical development and eventual partnering… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support to ... other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC,...The major responsibilities will include but are not limited to: Lead project core teams to ensure on time project… more
- Insmed Incorporated (NJ)
- …with serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and Controls (CMC) activities for the company's small ... executing the CMC strategy for all small molecule programs throughout their lifecycle , from preclinical development through commercialization. You will serve as a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and in line with Procurement policy. The end-to-end contract workflow process includes intake, draft, internal review, external negotiation, routing for financial ... agreements, license agreements, and amendments. The role will be utilizing Procurement's Contract Lifecycle Management (CLM) platform on a daily basis and will be at… more
