- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for a Director, Drug Safety. The Director, Drug Safety is responsible for planning, directing, ... stakeholders to ensure high quality submissions are made to the Food and Drug Administration (FDA) to meet company goals. ESSENTIAL FUNCTIONS Assists and supports… more
- Merck & Co. (Rahway, NJ)
- …company is seeking leadership of our Biologics and Mixed Modalities Drug Product Development teams, responsible for the scientific and technical oversight ... of our small molecule, large molecule, and mixed modalities drug product formulation design, process development, and innovation to establish and maintain a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible ... management of technology transfer of the manufacturing processes of (mAb, Drug Substance, Drug Product, or New Modality) for investigational and commercial drugs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently ... with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents… more
- Novo Nordisk Inc. (Boulder, CO)
- …method development and transfer of methods for oligonucleotide intermediates (IPC's) as well as drug substance and drug product release within a nonGMP lab. The ... Functions Provide analytical support for nonGMP manufacturing of Oligonucleotides ( drug substance) Conduct analytical method feasibility and transfers from the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …design and leadership of clinical development plans, and addressing all regulatory, drug and patient safety, data, CMC, IP, patient selection, market acesss and ... acumen.Providing best practices to DS's overall development strategy and drug development goals. Influencing their adoption and facilitating cross-functional… more
- Merck & Co. (Rahway, NJ)
- …part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology ... post-PCC to registration. Directors are leaders in the field of quantitative drug development, with a strong, integrated understanding of the strategic elements of… more
- Merck & Co. (Rahway, NJ)
- …prepare our company's teams for meetings with FDA at any phase of drug development. Lead cross-functional efforts to prepare for advisory committees and may speak ... compounds or marketed products throughout the entire life cycle of the drug .Represent GRACS within our company's internal committees to provide regulatory advice and… more
- Merck & Co. (Boston, MA)
- …and molecular design scientists who employ state of the art capabilities to drive drug design and development across the globe.- We are seeking a passionate people ... leader and accomplished computational drug hunter to lead a team of talented computational...strategic directions and help shape the future of computational drug discovery at our company. Key responsibilities will include:… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient ... drug discovery/development and/or regulatory decisions. The Pharmacometrics group within...independently with minimal supervision and/or lead QP2 efforts on drug /vaccine development programs, and author or co-author strategic documents.… more
- Merck & Co. (Rahway, NJ)
- …a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... pilot plant's mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial… more
- Merck & Co. (Rahway, NJ)
- …facility which is responsible for interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and ... is building a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) drug substance lab and the Specialist will become a subject matter… more
- Merck & Co. (Rahway, NJ)
- …state of the art capabilities in predictive sciences, AI/ML and structure-based drug design (SBDD) to accelerate our invention of therapeutics for patients.-We are ... globe to invent better molecules faster.- With an unbiased approach to drug modalities, in-house access to the newest screening techniques, and world-class medicinal… more
- Merck & Co. (Rahway, NJ)
- …a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a...to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for… more
- Merck & Co. (Rahway, NJ)
- …in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and Clinical Supply ... problems. Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient ... drug discovery/development and/or regulatory decisions. The Pharmacometrics group within...broad range of therapeutic areas, modalities and stages of drug discovery/development to independently provide day-to-day coaching/guidance to individual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …group to develop and apply QSP models to aid in drug discovery/development decisions, which include target prioritization, therapeutic modality selection, biomarker ... and apply Quantitative Systems Pharmacology (QSP) models to address drug -discovery and development questionsDevelop a QSP strategy to address prioritization… more
- Insmed Incorporated (Bridgewater, NJ)
- …associated with method development, qualification/validation, transfer and characterization for drug substance, drug product and reference standards. The ... products, reference standard qualification and physical (solid-state) characterization of drug product and drug substance.Prepares and approves technical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development ... with a more senior project manager in support of a larger, more complex drug development project. As a project manager this position is accountable for partnering… more
- Merck & Co. (Durham, NC)
- …Fermentation, and Purification). This position will primarily support vaccine drug substance site readiness via Validation program implementation, partnering with ... technology transfer, filing, and licensure for a new HPV vaccine drug substance manufacturing facility.Additionally, this role will contribute to the performance… more
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