- Merck & Co. (Rahway, NJ)
- …enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve as the primary technical contact ... Clinical Manufacturing, Compliance Reviews, Data Analysis, Environment Health and Safety , Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support,… more
- Genmab (NJ)
- …the CSRAttend trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of data ... Then we would love to have you join us!Role:The Associate Director acts as a statistical expert supporting the...and technical progress within the field of biostatistics in drug development and advise of new methodologies that may… more
- Aequor (Pearl River, LA)
- …in accordance with current relevant quality standards or standardized procedures and within safety guidelines in the production of Flublok Drug Substance in the ... downstream processing (Clarification and Purification) and buffer preparation areas of the cGMP commercial manufacturing facility. Requires good documentation skills and attention to detail. Duties will include the operation, maintenance, cleaning and… more
- Merck & Co. (North Wales, PA)
- …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… more
- Merck & Co. (Rahway, NJ)
- …and change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply… more
- Insmed Incorporated (San Diego, CA)
- …lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of ... Development Team representative as an Analytical Lead for a drug program.Key Responsibilities:Responsibilities include developing and optimizing analytical methods… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Operations Associate III as part of the Technical Operations team based in Raritan, NJ. ... warehouse space. This individual will assist in regulatory inspections, perform safety and quality audits, and answer relevant questions about packaging, methods,… more
- Eisai, Inc (Exton, PA)
- …difference. If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and ... focused on the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate (ADI) production… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as R shiny apps for data surveillance, visualization, modeling and simulations, and safety signal detection. Lead the development and validations of R package and/or ... R capabilities and implementations. Collaborate with CSPV to enable/effectively support safety signaling detections and across compounds safety reviews (ie,… more
- Genmab (NJ)
- …to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and ... and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …experience in PV; required10 or more years of experience within Drug Safety /Pharmacovigilance experience, including both investigational and marketed products; ... preferredExtensive knowledge of AE and drug coding conventions (MedDRA, WHO-DD). preferredExtensive knowledge of FDA regulations, clinical and safety databases,… more
- Merck & Co. (Durham, NC)
- …is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate ... to deliver Pharmaceutical, Biologic, and Vaccine Products. Our team works with a " Safety First, Quality Always" mindset.-As the primary point of contact for all… more
- Merck & Co. (Durham, NC)
- …North Carolina. This new facility will include end-to-end processing of both drug substance and drug product, including product inspection, warehouse, utilities, ... chest x-ray Position Responsibilities:This role reports to an Operations Associate Director and supports the product transfer for a...transfer for a new facility in Durham, NC within Drug Substance, Drug Product and/or supporting areas.Support… more
- Merck & Co. (Rahway, NJ)
- …team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates and Small Molecules, including ... Modalities, have a 10-15 group size composed of experienced, senior and associate scientists.- The successful candidate will effectively partner with Mixed Modality… more
- Kellermeyer (Clarksville, TN)
- Corrugate Recycler / General Warehouse Associate KBS is looking for motivated, high-energy General Warehouse Associates (Corrugate Recycler) to join our team for ... cleaning/janitorial services within large fulfillment centers. Our General Warehouse Associate (Corrugate Recycler) position performs the following duties within… more
- Kellermeyer (Clinton, TN)
- …TN. If you enjoy working in a fast-paced environment and helping make an impact on safety in the workplace, then this is the job for you! What are you waiting for, ... other items Some deep cleaning, as needed Follow all safety and quality standards Other basic janitorial duties as...walk for up to 10-12 hours Background Check and Drug Test Required Whats In It for You? At… more
- Merck & Co. (Rahway, NJ)
- …on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMPs) ... development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a variety of reagents,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …concise format.Perform tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with ... Operations.RequirementsH.S. Diploma with relevant experience required; or Certificate or Associate 's degree in a scientific or health services field preferred,… more
- Eisai, Inc (Phoenix, AZ)
- …Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with ... with internal cross functional partners including but not limited to Associate Director Regional Marketing, Oncology Field Reimbursement Managers, and other… more
- Ultragenyx Pharmaceutical (Bedford, MA)
- …Summary: ultra dedicated - Your biggest challenges yield rare possibilities The Manufacturing Associate III will be a suite based position within the Gene Therapy ... position is a suite/clean room based position where the Associate III position will be an on the floor...are available. Demonstrate a thorough and complete understanding of safety requirements, GMP compliance of the plant and process.… more
