- Merck & Co. (Rahway, NJ)
- …health. Responsibilities :Develops, coordinates, and provides biostatistical support for related drug /vaccine projects under supervision in Late Development ... clinical trials, and in coordinating the statistical activities for clinical drug /vaccine projects.The incumbent may initially work in a specific disease therapeutic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partners to ensure robust development of assay, participate in HA interaction for drug - related CDx topics/questions, and attend device company HA meetings as ... (Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into...: Assist with preparation of pre-submission documents and CDx related portions of therapeutic marketing applications and respond to… more
- Merck & Co. (Rahway, NJ)
- …degree in engineering or science plus a minimum of 3 years of related Drug Product/sterile experience. Required Experience and Skills :-Strong familiarity with ... and developmental supplies for sterile products, including critical program needs related to new products undergoing process development, new products undergoing… more
- Merck & Co. (Rahway, NJ)
- …high-volume clinical and commercial assembly equipment and processes for medical devices/ drug delivery systems. Reporting to the Director responsible for this area, ... equipment and processes for clinical and commercial manufacture of drug -device combination products.Hands on troubleshooting in a manufacturing environment with… more
- Merck & Co. (South San Francisco, CA)
- …Director, who will serve as the Computational Biology lead for Cardiometabolic Drug Discovery Data Science. We are seeking an experienced computational biologist ... our Company's investments in human genetics and other multimodal data to support drug discovery in the cardiometabolic disease space. This work will help to inform… more
- Merck & Co. (Rahway, NJ)
- …compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry sciences or related discipline with a minimum of 7 years of relevant work ... experience in manufacturing or development, in the areas of process start up, technology introduction, manufacturing and/or technical transferA minimum of 7 years of experience in manufacturing, specifically in API process production, development,… more
- Merck & Co. (Rahway, NJ)
- …as independent contributors, providing support for global and site-specific projects related to combination products and drug delivery systems.Facilitate the ... and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and… more
- Merck & Co. (Rahway, NJ)
- …experience OR a PhD in one of the above disciplines plus 5 years related experienceExperience with the development drug -device combination product or a medical ... Development & Technology (DD&T) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and… more
- Taiho Oncology (FL)
- …the field. Fulfill Pharmacovigilance responsibilities as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use ... may vary depending on multiple individualized factors, including market location, job- related knowledge, skills, and experience. The total compensation package for… more
- Merck & Co. (Rahway, NJ)
- …and engineers to design purification processes while develop ing technical strategies related to downstream processing for drug candidates in early- and ... years of industry experience and background in Chemical / Biochemical engineering, or a related field - - REQUIRED EXPERIENCE , SKILLS, AND COMPETENCIES - - Strong… more
- Merck & Co. (South San Francisco, CA)
- …biological constructs, and others. The Associate Director is a skilled quantitative drug developer, with a strong, integrated understanding of the strategic elements ... of drug discovery and development. The Associate Director should demonstrate...well as with external vendors and partners, on activities related to study design, protocol development, study execution, reporting… more
- Merck & Co. (Rahway, NJ)
- …cutting-edge capabilities in structure-based modeling, predictive science, and AI/ML to drive drug design and development globally, with a proven track record of ... teams on innovative science that has a wealth of opportunities to impact drug discovery and ultimately save and improve patient lives. Key responsibilities will… more
- Merck & Co. (San Francisco, CA)
- …of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and Clinical Supply ... Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical...Education Minimum Requirement: BS in biology, chemistry, engineering, or related field with a minimum of 8 years of… more
- Merck & Co. (Rahway, NJ)
- …broad deliverables including, but not limited to, API and Drug Product analytical problem-solving and optimization, trace impurity quantitation, characterization ... robust, and responsive supply chainIntroduce and lead strategic initiatives related to technical advancement, compliance, and business improvements.Demonstrate the… more
- Merck & Co. (San Francisco, CA)
- …Quantitative Pharmacology and Pharmacometrics (QP2) department drive model-informed drug discovery and development (MIDD) to routinely enable efficient ... drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced leadership team, deep modeling expertise and… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related discipline Required Experience and Skills :Deep drug ... 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)
- …(FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply ... GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will leverage leadership skills in strategic… more
- Merck & Co. (Rahway, NJ)
- …and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the Program CSPM designs strategic and operational ... chain areas to negotiate timelines ,- strategies and other related topics for all clinical supplies across all assigned...the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly… more
- Genmab (NJ)
- …LevelAct as lead and main point of contact related to Statistics for designated compound/indicationFollow scientific and technical ... progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficienciesEngage with… more
- Merck & Co. (Boston, MA)
- …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 QP2 brings an experienced leadership team, deep modeling expertise and… more