- Novo Nordisk Inc. (West Lebanon, IN)
- …will be responsible for initiating investigations and writing deviations in numerous cGMP areas for API manufacturing . The role will be responsible ... Experience:Minimum 3 years of experience conducting deviation investigations in a cGMP pharmaceutical manufacturing environmentExperience in a cGMP … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in ... Raritan, NJ. Role OverviewThe QA Manufacturing Excellence Manager role is an exempt...cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in supporting cell-based products is… more
- Merck & Co. (Durham, NC)
- …qualification/validation, equipment qualification, and technical support quality for sterile manufacturing of vaccines. The ideal candidate would have prior ... knowledge, thorough understanding of sterile manufacturing and background working with grade A,B, C and...meet performance objectivesConsults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …management or related field preferred. Previous experience & general knowledge in cGMP manufacturing & production processes preferred. Knowledge, Skills, and ... Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard… more
- Aequor (Thousand Oaks, CA)
- Onsite at ATO Looking for a Senior level PM who will support manufacturing plant and engineering group, This person needs to have process/utility Engineering ... quality background driven. This engineering position supports projects that associated with cGMP equipment and facilities at Thousand Oaks (ATO). The engineer will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of principles, concepts, practices, standards, validation, and qualification within a cGMP manufacturing environmentAdvanced proficiency in the use of ERP ... cGMP Warehouse Operations within a state-of-the-art cell therapy manufacturing facility. This individual will partner Technical Operations with other functions… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.Lead the daily start of ... a manner consistent with safety policies, quality systems, and cGMP requirements.Support manufacturing investigations, create/revise operational procedures,… more
- Aequor (Devers, TX)
- …Facility in accordance with Client policies, standards, procedures, and Global cGMP . Functional responsibilities include ensuring manufacturing compliance with ... procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with...stationed in Devens, MA and reports to the Senior Manager of QA Operations for the Devens SUF. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Agreements in order to assure that all external contractors involved in manufacturing and testing of drug products for commercial and investigational purposes, drug ... Management: Responsible to collect and/or evaluate data information from critical manufacturing steps process and authoring Annual Product Review as per internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key success factors.- Drive continuous improvement and maintain current knowledge of cGMP regulatory issues, Good Automated Manufacturing Practices (GAMP5) and ... Good Practices Guides, Risk-Based Approach/Computer Software Assurance (RBA/CSA) to assure related Daiichi Sankyo business needs are met. Maintain the Global DX global validation methodology in accordance with current regulatory guidelines.- Provide… more
- Novo Nordisk Inc. (Durham, NC)
- …of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable ... with Environmental Health & Safety (EHS) program requirements. Relationships Senior Manager - OFP. Essential Functions Create & maintain system specifications for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems such as SAP.Experience working with cell therapy is preferredKnowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based ... include material receipt, incoming inspection and release of materials required for manufacturing and release of patient material/final product of CAR-T at Raritan,… more
- Insmed Incorporated (San Diego, CA)
- …join the Quality Control leadership team. As the QC Stability and Sample Management Manager , you will be responsible for the daily oversight for the QC stability and ... and sample management (eg, JMP, Labware LIMS)Collaborate with Quality Assurance, Manufacturing and CMOs, Material Management, and other functions to ensure internal… more
- Merck & Co. (Rahway, NJ)
- …specification development, and hands-on troubleshooting to ensure process equipment ( manufacturing and packaging) and utilities remain functional and available to ... in engineering or science plus a minimum of 7 years of related manufacturing operations or engineering support experience. Required Experience and Skills :- Strong… more
- Merck & Co. (Durham, NC)
- …Hazardous Energy Control Procedures Compliance with current good manufacturing procedures( cGMP ), safety and environmental requirements/regulations/guidelines ... communication, and collaboration skills responsible for leads peers in supporting the manufacturing process. Individual will possess the ability to lead a team,… more
- Merck & Co. (Durham, NC)
- … manufacturing areas and operating under the direction of the Logistics Manager . Must adhere to current Good Manufacturing Practices, Standard Operating ... Requirement: High SchoolRequired Experience and Skills:-SAP, Forklift Operational Experience, cGMP Warehouse experience, working knowledge of Microsoft Office and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a manner consistent with the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager when data discrepancies are ... and release Drug Product QC Testing, related to the manufacturing of cell therapy products for clinical trials and...in a Quality Control setting is preferred. Knowledge of cGMP and GDP regulations and FDA/EU guidance related to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the CAR-T Equipment team in support of on-going clinical and commercial manufacturing as well as facility expansions and improvements.Key Responsibilities As an ... gets to work on this.You have strong knowledge of cGMP requirements. You document proposals to reach a solution...of this analysis can be conveyed to the Maintenance Manager in a structured way so that he can… more
- Catalent Pharma Solutions (Harmans, MD)
- …and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion ... Catalent Cell & Gene Therapy is a growing Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and… more
