- Merck & Co. (San Francisco, CA)
- …the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical ... Project Manager, will be responsible for implementing improved project management methodologies across DSCS Digital use -cases. The...of the areas of Drug Substance development, Drug Product development, Clinical Supply management… more
- Merck & Co. (Rahway, NJ)
- …to establish a consolidated , visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible for authoring ... communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong negotiation,… more
- Formation Bio (New York, NY)
- …built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or ... and more efficiently.About the PositionWe are seeking an Associate Director, Program Management to drive the execution of critical drug development programs… more
- Merck & Co. (Rahway, NJ)
- …scale-up, Drug Delivery and/or technology transfer experience including the use of gap analysis and risk assessment toolsHighly motivated, flexible, a change ... for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates...fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of… more
- Merck & Co. (North Wales, PA)
- …supports statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the ... be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM… more
- Merck & Co. (Rahway, NJ)
- …DayValid Driving License:NoHazardous Material(s):N/ARequired Skills:Adaptability, Capital Projects, Clinical Development, Detail-Oriented, Deviation Management , ... Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The FLEx sterile facility supports the formulation and filling… more
- Merck & Co. (Rahway, NJ)
- …benchtop to current Good Manufacturing Practice (cGMP) manufacturing facilities, our scientists use cutting edge science to transform drug delivery and ... drug delivery challenges Demonstrated understanding of connectivity between clinical development, chemistry, manufacturing and control (CMC) and commercial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThis position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with ... This individual will support organization build and ramp-up of clinical production and facility approval of a state of...review, approval and close out of work orders, including management of third-party vendor work, in accordance with established… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg, Diagnostic Development Teams) and to external diagnostic business partners specifically: Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice ... study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready...(Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into… more
- Formation Bio (New York, NY)
- …built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or ... applications. Whether you're helping the organization make sense of complex documents like clinical protocols and drug labels or building robust data pipelines… more
- Merck & Co. (North Wales, PA)
- …: This position supports statistical programming activities for late stage drug /vaccine clinical development projects. This may include leadership of ... be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards… more
- Insmed Incorporated (San Diego, CA)
- …Process Engineer will play a key role within the Manufacturing Sciences Department, supporting clinical GMP drug substance and drug product production and ... operations. This role combines technical leadership in equipment lifecycle management with oversight of calibration and maintenance systems to...not be responsible for any fees arising from the use of resumes through this source. Insmed will only… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for performing training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with ... Training team members in collaboration with management in Operations to support personalized cell therapy production...This individual will support organization build and ramp-up of clinical production and facility approval of a state of… more
- Merck & Co. (Rahway, NJ)
- …development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will ... teams.A strong mechanical aptitude.Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software.This role… more
- BioAgilytix (Durham, NC)
- …commitment to excellence and innovation, we tackle challenges across the spectrum of drug discovery to clinical diagnostics, driving advancements that shape the ... fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety… more
- Merck & Co. (North Wales, PA)
- …and plans for developmental compounds and obtains cross-divisional senior management approval.Critically assesses drivers and barriers to reimbursement and market ... identifies value evidence needs to provide strategic input into clinical and market development programs.- Brings strong payer and...of health care systems that can enhance value and use of products.Implements programs to document the burden and… more
- BioAgilytix (San Diego, CA)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... Manager II will lead scientific and operational activities in support of preclinical, clinical , and product release studies for our San Diego lab. This role requires… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be ... floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample management and...in a job environment with physical dexterity sufficient to use computers and document production records.Ability to handle human… more
- Genmab (NJ)
- …involved in the care of cancer patients. The Oncology Account Manager is a clinical and business leader who represents the values of Genmab by providing approved, ... sales goals for the territory by effectively positioning the benefits and use of Genmab's products for appropriate patients Demonstrates effective time management… more
- Merck & Co. (Rahway, NJ)
- …development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will ... - A strong mechanical aptitude. - Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software. - This role… more
