- Tris Pharma (Monmouth Junction, NJ)
- …the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Occupational ... Health and Safety Administration (OSHA) regulations, as well as all applicable company compliance guidelines, standards and objectives Leads and/or oversees functions (ie, purchasing/procurement, warehousing, logistics, etc.) to ensure day to day management… more
- Merck & Co. (Rahway, NJ)
- …(eg temperature monitors).- To provide SME guidance in support of small molecule drug substance and drug product container closure systems including mold ... qualification and regulatory compliance.- To act as master data stewards and support enterprise wide component specification management as well as maintaining documentation systems for the packaging community. The COE teams provide support to life cycle… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …development, and performance of all engineering operations across Raritan Carvykti drug product manufacturing. This role ensures that the manufacturing building, ... salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.Legend Biotech maintains a drug -free workplace. more
- Eisai, Inc (Nutley, NJ)
- …design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)Leads the development of Clinical Protocols to meet CDP ... on the Clinical Pharmacology and Translational Medicine aspects of drug development.A thorough understanding of standard Clinical Pharmacology computational… more
- AUROBINDO (Durham, NC)
- …systemic risks3. Analytical Testing OversightReview analytical testing of APIs, drug substances, finished products, packaging materials, and stability samplesEnsure ... pharmaceutical industry preferably in QA.Must be proficient with pharmaceutical drug manufacturing processes, cGMPs and other regulatory requirements.Experience in… more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... resulting in a proprietary pipeline including bispecific T-cell engagers, antibody- drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced… more
- Merck & Co. (Rahway, NJ)
- …Accountability, Communication, Data Governance, Data Modeling, Digital Transformation, Drug Development, Key Performance Indicators (KPI), Measurement Analysis, ... Medicinal Chemistry, Operating Models, Operational Excellence, Portfolio, Programme, and Project Support, Program Management, Project Management, Project Planning, Regulatory Documents, Risk Management, Roadmapping, SAP Master Data Governance (MDG),… more
- AUROBINDO (Durham, NC)
- …pharmaceutical industry, preferably with 3 to 5 years of experience in drug device combination product pharmaceuticals.Experience in release and stability testing of ... metered dose inhalers, Transdermal and Topicals, including chromatographic and product performance testing. Relevant experience should include tests such as aerodynamic particle size by cascade impactor, dose content uniformity, spray pattern, moisture… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.Legend Biotech maintains a drug -free workplace. ... Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reduction Act ("IRA") processes and compliance activities for the Medicare Drug Negotiation Program. Ensures accurate and timely input and implementation of ... 340B requirements as well as Maximum Fair Price ("MFP") effectuation requirements consistent with regulatory requirements, NNI policies and procedures and Sarbanes-Oxley regulations. Co-develop processes to validate 340B Program processes as well as MFP refund… more
