- Care Options for Kids (Piscataway, NJ)
- …of Registered Nurses (RN) Providing one-to-one nursing care in a home environment Taking direction from clinical team and being overseen by a registered nurse ... About the Role At Care Options for Kids, we provide 1:1 care in the home, and we do things a little differently. There's no revolving door of patients or hospital setting chaos blinking call lights, scurrying doctors, and wards bursting at the seams. Instead,… more
- Tris Pharma (Monmouth Junction, NJ)
- …Cleans up and removes garbage from various manufacturing locations throughout the company, including cGMP areas Sweeps and cleans floor as required and maintains ... Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the Study Manager and ... propose remediation plan.Distribute key study documents to the CRO and vendors as appropriate.- Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads all strategic sourcing efforts from vendor assessment, RFP, negotiation, award and contracting with senior business stakeholders for DS products and alliances.- ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Design, build, and maintain interactive dashboards and reports in Power BI to support FP&A deliverables such as KPI reporting, monthly management reporting, budget ... vs. actuals (BvA), rolling forecast analysis, and long-range financial planning (LRFP).Leverage low-code/no-code features (DAX formulas, Power Query, visualization tools) to develop scalable and user-friendly dashboards.Contribute to the Global Competitiveness… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi ... Sankyo's GxP group.Together with regional management teams plans, will support, conducts and reports internal systems and process audits across the organization as appropriate for the area of GxP audits assigned.Responsibilities:Execute the audit program for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads the development of the Global Medical Affairs strategy and execution of the Global Medical Affairs plan for select indications/projects related to evidence ... Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The primary responsibilities of the Director, Omni-Channel Marketing is to develop, plan and implement the overall omni-channel marketing strategy to key customer ... Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leadership, Direction, and Strategy: - In collaboration with Clinical Development and Clinical Operations as well as other BDM functions, sets the vision, direction, ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under supervision, with outsourcing to submit appropriate requirements on a project basis. Supports team in generating RFPs and in reviewing proposals and selecting ... vendors. This position also supports the management of the WO development and implementation.Supports packaging design and patient kit supply preparation, label generations and approvals and associated interactions with vendors. Supports regular vendor/sponsor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Internal Strategy and Operations- In alignment with senior colleagues, collect, review, and make decisions in collaboration with relevant Medical Affairs stakeholders ... on assigned TA educational grants and/or sponsorships- Design and implement internal communication plans to share educational and project outcomes metrics for the assigned therapeutic area(s)- As needed, in alignment with the Analyst Operations team/delegate,… more
- Tris Pharma (Monmouth Junction, NJ)
- …We have >150 US and International patents and market several branded ADHD products in the US We also license our products in the US and ex-US markets. We have a ... Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for supporting the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP ... environment. This role will ensure compliance within the document management system, document storage and retention, and document issuance and reconciliation.Key Responsibilities Serve as a Document Control reviewer for new and revised procedures and documents… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Review documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP).Review documentation for miscellaneous activities ... executed in accordance with Good Documentation Practices (GDP).Work in a team based, cross-functional environment to complete tasks required to meet all business objectives.Perform regular administrative duties to maintain all manufacturing record which will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Prepares and reviews documentation independentlyResponsible for QC sample and retain managementKnowledge and understanding of current Good Manufacturing Practices ... (cGMP) related to the QC laboratory and ability to identify gaps in processes or systemsProficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS)Prepare documents and coordinate Sample… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support and lead the execution of Indirect Procurement strategies at the site level across categories including, but not limited to:Materials: Lab supplies, PPE, MRO, ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for leading deviations and corrective actions in support of the QC testing laboratories related to the manufacturing of cell therapy products for clinical trials and ... commercial operations in a controlled GMP environment.Key Responsibilities Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.Review/complete routine CAR-T manufacturing nonconformance/deviation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for supervising the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, ... development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects.Key… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.Collaborate with site personnel to provide ... guidance and determine resolution for manufacturing issues.Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.Review and approve manufacturing procedures.Support regulatory inspections and… more
- Tris Pharma (Monmouth Junction, NJ)
- …Carries out responsibilities in accordance with company policies, SOPs, and state, federal and local laws Performs testing of raw materials, IP, FP and/or ST samples ... including dissolution, assay, related compounds analysis, content/blend uniformity, particle size distribution by Malvern/Sieve, bulk and Tap density, cleaning validation and other tests according to the analytical methods, United States Pharmacopeia (USP)… more
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