- 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 ... in Remotely. Role OverviewThis position represents a critical support role in the global MSAT organization. This individual will be responsible to support global process validation activities in support of the commercial Carvykti program both within Legend but… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Development and Commercialization Team (DCT) leader is-accountable for delivering a fully integrated stage-appropriate CMC development and ... will be responsible for advancing the company's biologics portfolio.Correspondingly, the DCT leader will be responsible for delivering world class outcomes in the… 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. The ... and finalization, and feed to the Submissions Assembly team. The Business Operations Lead should be able to understand the various source area processes and apply… 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
- 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 ... Provide technical support to help resolve technical queries and operational arisings Lead investigations and identify root cause and corrective action for in-service… 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 ... address key business questions. You will be an exceptional leader and active member of the Primary Market Research...responsibilities include and are not limited to the following: Lead a team of market research professionals (US and… 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
- Formation Bio (New York, NY)
- …acquiring and developing a portfolio of clinical-stage assets and looking for an IP leader who shares our vision and energy to protect, enhance, and maximize the ... value of these innovations throughout their entire lifecycle - from initial diligence through clinical development and eventual partnering or sale. Our preference is… 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
- 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 ... full compliance with established cGMP requirements. This individual will be a key leader in the Global Cell Therapy Quality organization and a champion for quality… more
- Insmed Incorporated (NJ)
- …and integrity in everything we do. We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems ... enterprise cybersecurity and risk strategy. This role requires a strategic, hands-on leader who can think globally, act decisively, and remain technically engaged in… more
- Merck & Co. (Rahway, NJ)
- …including novel biotherapeutics, vaccines, and engineered enzymes.As a senior scientific leader , the successful candidate will shape strategy, drive innovation, and ... microbial technologies.The ideal candidate for this position should be a recognized leader in the field, with demonstrated success in process development for the… 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 ... molecule pipeline. As a senior leader , you will oversee drug substance and drug product...CMC strategy for all small molecule programs throughout their lifecycle , from preclinical development through commercialization. You will serve… more
- Insmed Incorporated (NJ)
- …execution of the company's Global Medical Review Operations, overseeing the full lifecycle of the medical materials review and approval process. You will ensure ... the company's rare disease mission.What You'll Do: Manage and coordinate the lifecycle of medical materials, including submission, review, approval, and archiving in… more
- Merck & Co. (Rahway, NJ)
- …globally.-The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and pragmatic technical solutions to ... and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead … more
- Repligen (Waltham, MA)
- …enabling innovation across the bioprocessing manufacturing and product development lifecycle .This position requires strong collaboration with business leaders and IT ... through technology.This is an exciting opportunity for a strategic yet hands-on IT leader who enjoys partnering closely with the business and contributing to a… 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
- Syner-G BioPharma Group (Boston, MA)
- …with quality and regulatory requirements.Provide technical support for the product/process lifecycle and related activities.Support client requirements to lead ... the life sciences industry, supporting critical phases of the drug development lifecycle , from discovery and regulatory approval to technology transfer and the… 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
