- Novo Nordisk Inc. (Boulder, CO)
- …Support the technology transfer of manufacturing processes into Phase I/II cGMP Manufacturing Facilities Responsible for routine communication to all levels ... Pilot Plant and is responsible for the production of non- cGMP oligonucleotide API to support toxicology studies. In addition...and cost to the overall operation. Relationships Specialist, API Manufacturing reports to the Senior Manager , API… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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 Overview The 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
- Novo Nordisk Inc. (Boulder, CO)
- …with or at CMOs/CROs is required Working knowledge of regulations associated with GxP/ cGMP manufacturing is require Strong project management skills are required ... ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is...The Senior Manager of Specialty Raw Materials Manufacturing is responsible for ensuring a steady supply of… more
- Merck & Co. (Durham, NC)
- …Experience leading instructor-led or hands-on training Experience with shop-floor cGMP manufacturing and familiarity with pharmaceutical regulatory requirements ... Job DescriptionPosition Description: Human Papilloma Virus ( HPV) Operations Manager , Training Center Durham's DS4 Operations Training Center Manager will be… more
- Merck & Co. (Durham, NC)
- …/military service Required Experience and Skills: Minimum 4 years production/ manufacturing experience, preferably in a cGMP environmentDemonstrate ability ... the selected individual must become proficient in the use of manufacturing systems and knowledgeable of site procedures to resolve process/equipment issues,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …incorporated with an automation platform that integrates with MES systems in cGMP manufacturing operations. This effort will extend organizationally to ... in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in… 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 ... well as internal stakeholders for the success of the Site. Relationships Manager , FUSE. Essential Functions Ensures all safety & environmental requirements and… more
- Merck & Co. (Durham, NC)
- …quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an ... interdependent global manufacturing network committed to deliver a compliant, reliable supply...to include the following:Direct in-line Quality support for all cGMP compliance, batch review, and environmental monitoring matters.Review and… more
- Catalent (Manassas, VA)
- Scheduling ManagerPosition SummaryThe Scheduling Manager will work with the Site Leadership team and the extended functional leaders to take over the daily ... coordination and planning with various departments working closely with Purchasing, Manufacturing , Logistics to support clear execution of the daily and weekly… 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 ... in a manner consistent with safety policies, quality systems, and cGMP requirements. Support manufacturing investigations, create/revise operational procedures,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized products. Lead the validation team ... resource to improve product quality, reliability, and process capability. Support manufacturing to satisfy the quality and process validation requirements for… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems processes. Implement processes to ensure compliance with current Good Manufacturing Practices ( cGMP ). Manage multiple and complex cross-functional ... responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Merck & Co. (Durham, NC)
- …skills and experienceMinimum of 5 years of knowledge of pharmaceutical manufacturing facilities, plant operations, maintenance, vaccine processes, and industry ... cGMP guidelines and practices is highly desirableExperience managing small...daily in-person attendance is required for, field-based positions; facility-based, manufacturing -based, or research-based positions where the work to be… more
- Aequor (Libertyville, IL)
- …Knowledge of various IT Systems integration and Agile Methodologies. Knowledge of cGMP , GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation ... understanding and supporting the integration between Enterprise IT Systems and Site Manufacturing , Laboratory IT Systems and Data Analytics. This role will support… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… 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 ... help us make what matters. The Position Establish a satellite team in Manufacturing Development Life Cycle Management (Mdev LCM) in Emerging Technologies (ET) for… more
- Catalent (St. Petersburg, FL)
- …trending and follow-up of the CAPA programs. Interacts directly with the manufacturing personnel and is responsible for maintaining a high-quality environment within ... the manufacturing area by overseeing and ensuring compliance with current...for the QA Specialists.Provides feedback to QA Supervisor and Manager on performance of QA Specialists.Responsible for actively identifying… more
- Merck & Co. (Durham, NC)
- …Hazardous Energy Control Procedures.Compliance with current good manufacturing procedures( cGMP ), safety and environmental ... communication, and collaboration skills responsible for leads peers in supporting the manufacturing process. Individual will possess the ability to lead a team,… more
