- Merck & Co. (Rahway, NJ)
- …to high-volume clinical and commercial assembly equipment and processes for medical devices/ drug delivery systems. Reporting to the Director responsible for this ... with a focus on DFM/DFA principles.Understanding of autoinjector/parenteral/pre-filled syringe delivery device design and function, and the ability to develop… more
- Merck & Co. (Rahway, NJ)
- …FAT/SAT, start-up, qualification and/or validation is preferredFill/finish process scale-up, Drug Delivery and/or technology transfer experience including the ... team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates and Small Molecules, including… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers ... for global and site-specific projects related to combination products and drug delivery systems.Facilitate the professional development and performance of… more
- Merck & Co. (Rahway, NJ)
- …quality advice to stakeholders creating optimal development, commercialization, and drug / delivery device supply strategies-Building our leadership and functional ... regulatory activities with cross- product or cross-functional impact, including drug device/combination products and software as medical device platforms.- Reviews… more
- Merck & Co. (Durham, NC)
- …is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate ... but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply: Build a strong interdependent relationship with… more
- Merck & Co. (Rahway, NJ)
- …& Technology (DD&T) organization designs, develops, and commercializes novel biologic/ drug / vaccine - device enabled combination products to achieve safe and ... effective delivery to their intended site of action. The DPPD...set direction for the device development strategy for multiple drug -device combination product development programs ranging from concept generation/selection,… more
- Merck & Co. (Rahway, NJ)
- …the process is scalable without compromising stability, safety, efficacy, and delivery . -During development, we leverage smart experimental design, cutting edge ... In summary, our team enables the translation of preclinical candidates into non-oral drug products.We are seeking a highly motivated candidate for the position of… more
- Merck & Co. (Rahway, NJ)
- …accelerate the decision-making process from hit identification to clinical candidate delivery across different therapeutic areas and modalities at our company.M&I is ... in structure-based modeling, predictive science, and AI/ML to drive drug design and development globally, with a proven track...science that has a wealth of opportunities to impact drug discovery and ultimately save and improve patient lives.… more
- Merck & Co. (Rahway, NJ)
- …of the art capabilities in predictive sciences, AI/ML and structure-based drug design to accelerate our invention of transformative therapeutics for patients.-We're ... therapeutic discovery.We are seeking a strategic thinker and accomplished computational drug hunter to take on leadership of our peptide modeling capability.… more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... procedures for blinding are in place as applicableSupport timely delivery of statistical deliverablesResponsible for planning and conducting trial result… more
- Merck & Co. (Rahway, NJ)
- …s .- GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning (Planning) ... the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly...s used within the assigned program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug … more
- Formation Bio (New York, NY)
- …is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses… more
- Tris Pharma (Monmouth Junction, NJ)
- …the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Occupational ... to ensure continuity of supply while optimizing cost, quality and delivery for internal and external stakeholder satisfactionCollaborates cross functionally with… more
- Merck & Co. (Rahway, NJ)
- …Development & Technology (DD&T) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... effective delivery to their intended site of action.- The DD&T...disciplines plus 5 years related experienceExperience with the development drug -device combination product or a medical device component of… more
- Merck & Co. (Rahway, NJ)
- …data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes ... electronic submission process and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness.… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …be part of Legend Biotech, a leading cell therapy company with commercial CAR drug product CARVYKTI and an attractive pipeline portfolio. The candidate will be an ... advance the next generation of cell therapies using cutting edge in vivo gene delivery technologies and create innovative novel CAR designs for a wide range of human… more
- Aequor (Thousand Oaks, CA)
- …strive to serve every patient, every time. In this critical role for the Thousand Oaks Drug Product (DP) facility, - also known as ATO B20 - you will be responsible ... submissions while delivering NPI project(s). Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and… more
- Eisai, Inc (Indianapolis, IN)
- …market and influential patterns within markets.Experience with ambulatory/clinic oncology delivery pertaining to infused and oral, specialty pharmacy distribution ... environmental, and operational stakeholders and drivers within highly integrated oncology delivery systems.Experience in key local and national, health care issues… more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... Ensure procedures for blinding are in place as applicable Support timely delivery of statistical deliverables Responsible for planning and conducting trial result… more
- Merck & Co. (Rahway, NJ)
- …s .- GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning (Planning) ... establish a consolidated , visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible for authoring clinical supply… more
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