- Merck & Co. (North Wales, PA)
- …- Responsibilities : This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership ... of one or more projects.-Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual… more
- Merck & Co. (Rahway, NJ)
- …a passionate and skilled individual to lead the charge in transforming our late -stage pipeline and commercial products into reality.What You'll Do:As a key player in ... Participate in and/or spearhead cross-divisional technical teams focused on late -stage clinical process development, characterization, and technology transfer of… more
- Merck & Co. (Rahway, NJ)
- …the technical leadership and laboratory capabilities in support of late -stage pipeline commercialization and post-market commercial manufacturing support. BDSC ... conjunction with internal and external partners, this individual will support late stage and commercial large molecule biologics program activities. The individual… more
- Merck & Co. (North Wales, PA)
- …benefit of patients and global human health.The Associate Vice President (AVP), Late Development Statistics, BARDS, is responsible and accountable for the end-to-end ... statistical support for a number our company's late -stage products in Oncology. The AVP will work under...The AVP will work under the direction of the Late Development Statistics Vice President in BARDS and will… more
- Merck & Co. (North Wales, PA)
- …are in various stages of development therefore requiring someone who has late vaccine clinical development and lifecycle management experience.The AVP will also be ... with functional experts across the enterprise to ensure operational excellence in the late development of assets within the pediatric section of the Vaccine Clinical… more
- Merck & Co. (North Wales, PA)
- …position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly ... includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application… more
- Merck & Co. (Rahway, NJ)
- …process characterization, technology transfer, validation, filing and supply support of late -stage projects in the small molecule pipeline.- Given the significant ... role of biocatalysis and enzymes in the portfolio, the ideal candidate should have a specific expertise in microbial fermentation and downstream processing and is expected to draw on their expertise to optimize and fully characterize the enzyme manufacturing… more
- Merck & Co. (Rahway, NJ)
- …Biologics Operation (GBO) sites for successful PPQs and PAIs for late -stage pipeline biologics.Drive the launch readiness and launch effectiveness hoshin/strategy ... across the internal manufacturing network.Partner with site leadership to drive preparedness for agile and efficient multi-product manufacturing operations.Establish and lead a cross-functional launch readiness governance model across global sites and… more
- Merck & Co. (Rahway, NJ)
- …processing and recombinant expression of drug candidates in early- and late -stage development.Responsibilities include, but are not limited to:Serve as a scientific ... leader to shape and drive innovation across the Biologics pipeline, strategy, and science.Anticipate and solve scientific and technical challenges across projects and functional teams, in a fast-paced, multidisciplinary environment.Lead the development of… more
- Merck & Co. (South San Francisco, CA)
- …on cardiometabolic and ophthalmology discovery, early clinical development and late clinical development teams, leveraging quantitative approaches to drive ... streamlined development of programs within our growing ophthalmology portfolio. Collaborate with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact… more
- Merck & Co. (Rahway, NJ)
- …strategic plans for technology transfer, problem-solving, leading working group in late stages of development, and working collaboratively with receiving sites, drug ... product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early development teams to ensure needs of manufacturing are considered as part of the design.- Provide information and drive early alignment and… more
- Merck & Co. (Rahway, NJ)
- …to upstream processing and recombinant expression of drug candidates in early- and late -stage development .- Responsibilities include but are not limited to: As an ... impactful contributor, shape and realize innovation across the Biologics' pipeline, strategy, and scienceAdvance the pipeline by collaborating with cross-functional teams, from Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate… more
- Merck & Co. (Rahway, NJ)
- …support for related drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory, Statistical Programming, ... Data Management and other company Research Laboratories Scientists in designing and analyzing 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)
- …Having knowledge of all phases of drug development, including early and late phase clinical development and submission required- Having solid background of applied ... statistics required- Solid knowledge of new advanced statistical methods using SAS or R required- Advanced knowledge in database structures and set-up required Travel: Ability to travel up to 10% Company is committed to diversity and inclusion. We are an equal… more
- Merck & Co. (North Wales, PA)
- …the project as needed.-This includes the following activities:1. Is involved in late clinical development planning (LDP) to ensure that study designs are consistent ... with program objectives and meet worldwide regulatory and marketing needs.2. Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions, and carries them… more
- BioAgilytix (Boston, MA)
- …proactively informing Customer Service of any issues which may cause late results.Performing and documenting routine equipment use, maintenance, calibration as well ... as routine, scheduled, and unscheduled preventive maintenance.Participating in method development and equipment qualification activities as directed by Laboratory Management.Supporting audits, inspections, and assisting in responding to observations, if… more
- Aequor (North Creek, WA)
- …in a development/MSAT lab or in manufacturing operations. This role will support late stage and commercial projects through bench scale and pilot scale cell culture ... experiments. The ideal candidate would be comfortable in a fast-paced environment where they are required to troubleshoot technical challenges and apply innovative technologies to solve manufacturing problems. The incumbent will work in a highly collaborative… more
- Merck & Co. (Rahway, NJ)
- …substance process development activities to enable and accelerate early and late -stage pipeline programs using fed-batch and continuous manufacturing platforms. The ... Director, Biologics Process Development (BPD) within the Biologics Process Research and Development (BPR&D) organization is responsible for designing and implementing novel bioprocess technology platforms and processes for upstream and downstream processes… more
- Genmab (NJ)
- …of compounds as compound and/or indication lead for both early and late -stage programs, and/or as trial responsible statistician with responsibilities as described ... below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and main point of contact related to Statistics for designated compound/indicationFollow scientific and technical… more
- Merck & Co. (Rahway, NJ)
- …technical strategies related to downstream processing for drug candidates in early- and late -stage development . - - Responsibilities include but are not limited to: ... - - Asan impactful contributor , shape and realize innovation across the Biologics ' pipeline, strategy, and science - Advance the pipeline by c ollaborat ing with cross-functional teams, from Research & Manufacturing, in a fast-paced, multidisciplinary… more
