- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial member of our team, responsible for spearheading risk management efforts in ... combination product development, commercialization, and lifecycle management. This individual will oversee device risk management activities to ensure the delivery… more
- Merck & Co. (Rahway, NJ)
- …ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process . ... feed to the Submissions Assembly team. The Business Operations Lead should be able to understand the various source...and function as BSOLead the Change Management and Business Process activities to drive adoption of the new solutionSupport… 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
- Rolls Royce (Indianapolis, IN)
- …the complete job description and applying promptly. Job Description Job Title: Lifecycle Engineer - Mature Engines Program Working Pattern: Full time Working ... support to help resolve technical queries and operational arisings Lead investigations and identify root cause and corrective action...us and are an essential component of our assessment process . They are the fundamental qualities that we seek… more
- Merck & Co. (Rahway, NJ)
- …at local, regional and global levels to enable value-driven decision making. You will lead and coach a team of market research professionals (both US based and ... changing environment. Key responsibilities include and are not limited to the following: Lead a team of market research professionals (US and global) to design and… 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. (North Wales, PA)
- Job DescriptionReporting to the CFA Strategy and Operations Lead , the Customer Facing Application (CFA) Strategy and Operations Senior Specialist executes the ... progress, and for risk mitigation Partnering with technical and/or strategic partners to lead the implementation of capabilities Define and execute against a plan to… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Quality team based in Raritan, NJ.Role OverviewThe Sr. Director of Quality will lead Legend CAR-T manufacturing facilities within the United States and ensure the ... transition activities and responsibilities for Legend.Key ResponsibilitiesServes as the Quality Lead in support of cell therapy manufacturing and operations within… more
- Merck & Co. (Durham, NC)
- …will direct Shop Floor Quality Assurance (SFQA) B160 to support process and technology introduction, compliance improvements, and manufacturing readiness to initiate ... manage Shop Floor Quality Assurance team on second shift. Lead a Shop Floor QA team to provide end-to-end...Media, Drug Substance and Drug Product throughout the project lifecycle . Ensure all aspects of the Shop Floor QA… 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
- 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
- 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
- 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
