- Merck & Co. (North Wales, PA)
- … drug development and clinical trial processes, including related standards and documents, and GCD organization, roles and responsibilities.-Knowledge of the ... Global SME for assigned topics and SOPs, the Global Clinical Development (GCD) Standards & Training Lead (STL) will work closely with Quality and Continuous… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... timely release and delivery of pharmaceutical products as per applicable regulatory standards and company expectations for products. The incumbent is responsible to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible… more
- Aequor (Seattle, WA)
- …Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development. Familiarity with alliance management Job Description The ... or the development portfolio as a whole, with a particular focus on Drug Product Process Development support and alliance management. The Technical PM will work… more
- Merck & Co. (Durham, NC)
- …are manufactured, tested, and distributed in alignment with our high standards of quality. Partnering across our internal manufacturing facilities, external contract ... patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... global regulatory plans support a precision medicine approach eg integrated drug /diagnostic regulatory and submission plans), including HA engagement plans and… more
- Merck & Co. (Rahway, NJ)
- …This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our company's pipeline to identify ... as the opportunities arise, develop new and novel delivery technologies.These drug delivery device technology platforms are often assemblages of injection molded… more
- Merck & Co. (Rahway, NJ)
- …company's Device Development (DD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... your leadership.Remain current in relevant worldwide regulatory guidance and standards .Lead/support/oversee clinical supplies production with respect to device component… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... performed by direct reports or staff of the global function to support drug development and life cycle management. Represents the function in global regulatory/heath… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... Summary The Sr Director GPM&L is accountable for delivering an integrated drug development strategy and tactical plan including options analysis of team's proposals… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... immune disorders.SummaryThis position is responsible for providing project management, drug development expertise to Global Project Teams including strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... of results with supervision. This position contributes to specific aspects of drug development plans with supervision and contributes to documents submitted to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... group to develop and apply QSP models to aid in drug discovery/development decisions, which include target prioritization, therapeutic modality selection, biomarker… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... with IRT systems and support in managing the forecasting and planning of drug supply needs. Can participate effectively on a cross functional and on Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... QA GMP activities pertinent to the overall compliance state of DS drug substance, drug product and packaging manufacturing sites of DS products. These sites… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …includes engineering, maintenance and validation projects. Track and maintain standards and calibration certificates. Supports department in creation and tracking ... local, state and federal regulations including and equivalent to Federal. Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... strongly preferred- Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including clinical,… more
- Catalent (Manassas, VA)
- …production chain from receiving to dispatching. To ensure adherence to company quality standards procedures and policies. Inform the QA management if any out of ... check of lines to ensure products meet established quality standards before, during and after production; Perform daily checks...rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
