- 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 ... to cGMP requirements. This individual will support organization build and ramp-up of clinical production and facility approval of a state of the art cell therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …across all functions and sites.Support the development of the GMP Compliance program related to clinical / commercial stage and manufacturing.Support Legend's ... will be responsible for providing quality oversight over the compliance program within the global quality organization to ensure harmonization, alignment and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …patients.Key ResponsibilitiesLeads, coaches and delivers a holistic, effective process qualification program for Operations trainees who support daily clinical ... process training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will work within… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training activities for Quality Control Microbiology team members who support cGMP Clinical and Commercial Cell Therapy testing. This role will require technical ... knowledge, and skills assessments.Optimizes the effectiveness and efficiency of training program in delivery of qualified personnel.Work cross functionally with the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ... procedures.Support cross-functional projects with many stakeholders.Participate in the training program for new members.Perform tasks in a manner consistent with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ... within quality systems processes.Key Responsibilities Provide oversight to the CAPA program for the CAR-T manufacturing site.Oversee metrics, trending, and reporting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This position will also be responsible for establishing and reporting on key project/ program metrics in support of on time and on budget project deliverables.Key ... and implications assessment (value, risk, cost, time) to the project or program .Prepares and manages MES governance interactions in partnership with the Project… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …engineering support for building automation and controls systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be ... collaboration across relevant cross functional groups to establish a strong, compliant program to enable robust production, testing and release of product to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing operational excellence continuous improvement support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead ... executes against an effective, holistic continuous improvement and problem solving program to improve safety, compliance, cost, process stability building quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be ... across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.Key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program ; tuition reimbursement program ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program ; tuition reimbursement program ... Commercial, Market Access and Public Affairs, Legal, Finance and Investor Relations, Clinical , Medical and Regulatory, plus other cross functional teams as needed.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program ; tuition reimbursement program ... contracts service provider. Strong understanding of key contract provisions. Commercial (ie non- clinical ) contract experience is preferred A minimum of 5 years of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program ; tuition reimbursement program ... supporting various company initiatives and functions such as Marketing, IT, Clinical , Research, Operations, Patient Support Programs, and Digital Health Lead cross… more
- Merck & Co. (Rahway, NJ)
- …with subject matter experts to translate disease biology and drug mechanism into clinical stage biomarker plans that address key program questions and integrate ... Job DescriptionTranslational Biomarkers (TB) develops and validates clinical biomarkers to support decision making across the development lifecycle for all… more
- Merck & Co. (Rahway, NJ)
- …This position supports statistical programming activities for Early Oncology clinical development projects, Aggregated Safety Analysis and Secondary Publication. ... of statistical datasets that support multiple stakeholder groups which include clinical development, and safety evaluation. The position is a key collaborator… more
- Merck & Co. (Rahway, NJ)
- …programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Merck & Co. (Rahway, NJ)
- …drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory, Statistical Programming, Data Management, and other Scientists ... from our Research & Development Division in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine… more
- Merck & Co. (Rahway, NJ)
- …This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.-The… more
- Merck & Co. (Rahway, NJ)
- …availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. This will require routine interaction with ... Ops Engineering). The FLEx facility supports the formulation and filling of clinical , stability, and developmental supplies for Oral Solid Dosage (OSD) and… more
