- Bristol Myers Squibb (Summit, NJ)
- …Senior Managers, Managers, Team Leads and Material Handlers that interface with GMP cleaning and EM sampling partners responsible for all processes associated with ... GMP cleaning & EM Sampling within CAR T clinical...(future 12hr/7d Operation). This position assures individual and group compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA,… more
- Merck (Rahway, NJ)
- …and change management + Experience with quality systems + Familiarity with US and EU GMP and Safety compliance regulations + Experience with SAP, ERP or MES ... a launch pad for the early phase and commercial formulation development and GMP clinical supply manufacture of our Company's drug product pipeline. The FLEx Sterile… more
- Bristol Myers Squibb (Summit, NJ)
- …Sample Storage in Cryotanks), Patient Materials Mgmt (APH receipt and DP Packout), GMP Cleaning and EM Sampling within CAR T clinical and commercial operations in ... all tasks of MSS organization ranging for EM Sampling, GMP Cleaning, APH receipt, DP Packout, sample retrieval, sample...(future 12hr/7d Operation). The position assures individual and group compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA,… more
- Bristol Myers Squibb (Summit, NJ)
- …Cell Therapy manufacturing processes, maintaining a culture of safety, compliance , innovation, and Continuous Improvement within the Manufacturing Operations ... adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion ** GMP ** + Is accountable to ensure their Manufacturing Managers and their WCT… more
- Bristol Myers Squibb (Summit, NJ)
- …- Friday, Standard Working Hours **Responsibilities:** + Foster a culture of compliance and technical expertise with a foundation of strong environmental, health, ... authorities as required to support pre-license inspections and subsequent routine GMP inspections. + Build and evolve the organizational structure to maximize… more
- Bristol Myers Squibb (Summit, NJ)
- …to ensure their WCT members maintain a culture of safety, compliance , innovation, and Continuous Improvement within the Manufacturing Operations function. This ... adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion ** GMP ** + Is accountable to ensure their WCT members execute the manufacturing… more
- Insight Global (Rahway, NJ)
- …support consistent documentation and process standardization across the organization. Ensure compliance with GMP , FDA, and other regulatory standards throughout ... We are seeking a highly skilled and motivated Process Engineer / Subject Matter Expert (SME) with 2+ years of Drug Substance / Drug Product experience in… more
- Merck (Rahway, NJ)
- …+ Defining and implementing operational control strategies to ensure efficient GMP processes while maintaining high-level of compliance and scientific ... our small molecule portfolio. In this role, you will work with the GMP Analytical and Raw Materials teams on strategies associated with Operational Excellence. The… more
- Bristol Myers Squibb (Summit, NJ)
- …guidelines. **Knowledge & Skills:** + Must have advanced knowledge and experience with GMP , Quality, and compliance . + Able to write and review technical ... + Responsible for ensuring accurate printed information on labels in compliance with health authority requirements. + Coordinates with production teams to… more
- Merck (Rahway, NJ)
- …a new multi-modality (small molecule, biologics, vaccine) Drug Product development and GMP clinical manufacturing plant in Rahway, New Jersey. The FLEx organization ... not limited to: + Become an MES subject matter expert and apply knowledge of manufacturing processes to partner...MES system is in a state of control and compliance . + Participates in the creation and execution of… more
- Merck (Rahway, NJ)
- …chain metrics and/or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise. + Mentors new team members and ... in project / portfolio management. + Knowledge of Good Manufacturing Practices ( GMP ) and Good Clinical Practices (GCP) is highly desirable. **Preferred Experience… more
- Bristol Myers Squibb (Summit, NJ)
- …and multiple shifts (future 12hr/7d Operation). The position assures individual and group compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs and ... procedures, and corporate policies while maintaining a culture of safety, compliance , innovation, and Continuous Improvement. **Shifts Available:** Monday - Friday,… more
- Bristol Myers Squibb (Summit, NJ)
- …and multiple shifts (future 12hr/7d Operation). The position assures individual and group compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs and ... procedures, and corporate policies while maintaining a culture of safety, compliance , innovation, and Continuous Improvement. **Shifts Available:** Monday - Friday,… more
- Merck (Rahway, NJ)
- …develop and maintain global training materials, and be a subject matter expert on information systems supporting change control. **Primary activities include, but ... A robust and sustainable change management process is critical to ensure compliance with regulatory dossiers and compliant supply. The selected candidate will work… more
- System One (Mahwah, NJ)
- …the internal QC change control system + Applies expertise of compliance requirements and therefore maintains an inspection-ready state laboratory + Participates ... as subject matter expert during audits/inspections + Works with internal departments and...immunology experience in a CGMP/GTP environment a must + GMP , Cell count, flow cytometry , documentation, flexibility, CBC,… more
- Bristol Myers Squibb (Summit, NJ)
- …the ALCOA+ principles. + Perform Cell Therapy production steps to maintain hands-on expert knowledge of each Unit Operation, role model good execution and behaviors ... and CAPAs as required to restore area performance and ensure optimal compliance levels. Identify strategic and operational issues both internally and externally,… more
- Merck (Rahway, NJ)
- …clinical supply planning group (eg, process improvement initiatives, subject matter expert roles, cross functional projects, etc.) + Demonstrates high capability to ... in project / portfolio management. + Knowledge of Good Manufacturing Practices ( GMP ) and Good Clinical Practices (GCP) is highly desirable. **Preferred Experience… more
- Merck (Rahway, NJ)
- …documentation + Support validation of new software and technologies validation for GMP application + Ensure digital solutions are deployed in conjunction with ... DOE design and data analysis (eg, JMP or Design Expert software). + Business Knowledge: High performance in delivery...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los… more