- Merck & Co. (Rahway, NJ)
- …Development Division's microbiology team is seeking a Director for the Rahway NJ GMP microbiology operations.- The primary objective of the position is to oversee ... GMP environmental monitoring and microbiological release of pipeline products.-...release of pipeline products.- The director will provide guidance, lead activities, and strengthen a team of microbiologists whose… more
- Insmed Incorporated (NJ)
- …Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP ... Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and...GMP requirements and ensuring alignment with global Quality strategy. Lead and develop a team of 2-8 Quality professionals… more
- BioAgilytix (Durham, NC)
- …Cytometry, ELISA, qPCR, ddPCR, USP CompendialsPrepare plate mapsServe as lead analyst on sample analysis projectsTroubleshoot assaysCompile/process data (make power ... export)Prepare summary tablesPeer review raw dataOrder reagentsParticipate in assay development and validationAdhere to provided method/directivePrepare buffersUse LIMS systemParticipate in sample analysisPipettingAdhere to safety requirements Keep accurate… more
- Merck & Co. (Durham, NC)
- …12.5 hour (6:30 PM-6:30AM) rotation (2-2-3). - The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with ... expertise working in aseptic production and manufacturing operations. -The Lead Technician is a manager developmental role and will serve on the Operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe ... Quality Systems Lead role is an exempt level position with responsibilities...support both clinical and commercial requirements in a sterile GMP environment. This role will serve as the business… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigation Lead is an exempt level position reporting to the...of a personalized cell therapy product in a sterile GMP environment. The ideal candidate for this role demonstrates… more
- Merck & Co. (Rahway, NJ)
- …Operations, is responsible for independent approval of documentation to support GMP clinical supply drug product manufacture, testing, release, and maintenance in ... inspections of facilities or operations in supported areas, including GMP Certification inspection. Education Minimum Requirement:- BS in appropriate Science… more
- Merck & Co. (Rahway, NJ)
- …automation representative for new products, process changes, and operational improvements; lead cross-functional teams and participate in tier meetings to drive ... user/role administration, patching, backups, disaster recovery, and virtualization in GMP operationsCollaborate with GES, FM/GWES, Quality, Manufacturing Operations, OEMs,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over the...support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations,… more
- ValSource, Inc. (Worcester, MA)
- …technically skilled leaders in Process/Process Equipment Engineering to support exciting GMP Drug Substance and Drug Product capital projects throughout our network ... our clients’ Process Engineering programs within Pharmaceutical and Biotech GMP manufacturing facilities. This includes systems and equipment used...to act in the best interest of the client. Lead the project through an offsite design effort (at… more
- ValSource, Inc. (Rahway, NJ)
- …currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting ... projects with our clients in the pharmaceutical and biotech and related GMP manufacturing industries throughout each of our regions in the US. The Commissioning,… more
- Cipla (Fall River, MA)
- …AM - 5:00 PM (May vary based on business needs) Reports To : QA QMS Lead Salary Range : $64,272 - $77,662 PURPOSE The QA Document Control Associate in a ... responsible for managing controlled documents to ensure compliance with GMP , GDP, and regulatory standards such as FDA 21...Quality Team. The position reports to the QA QMS Lead and may be matrixed to other functional leaders… more
- Merck & Co. (Ames, IA)
- …and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below aspects of ... and Animal Health global auditing program:ResponsibilitiesPerform comprehensive and detailed GMP compliance audits of animal health sites, contractors, business… more
- Repligen (Clifton Park, NY)
- …industry, and GMP standards. Successful performance at this level can lead to progression to a Sr. Packaging Technician.Second shift Operators receive a +$1.00 ... procedures (SOPs) and maintain compliance with Good Manufacturing Practices ( GMP ).Identify and report any quality or process deviations to supervision.Support… more
- Merck & Co. (Durham, NC)
- …works to coordinate, develop and implement Corrective Actions/Preventive Actions (CAPAs) Lead implementation of MPS principles on the shop floorSample ... degree and at least One (1) year of experience in a direct GMP , biotechnology, manufacturing setting.Required Experience and Skills: Experience working in a GMP… more
- Eisai, Inc (Exton, PA)
- …manufacturing steps per production scheduling, material staging, equipment set-up, and GMP operations in the Biologics Operations group. The Sr. Manufacturing ... monitor the process performance, assist troubleshooting, and adhere to GMP documentation ensuring compliance to relevant regulations. The Sr. Manufacturing… more
- Merck & Co. (NC)
- …involving utility system generation, distribution and control are preferred. Lead in the identification and implementation of process improvement projects, ... Quality approvers. Perform a thorough review of engineering records and related GMP documentation, identifying and resolving discrepancies in a timely manner, and… more
- Lundbeck (North Hyde, SD)
- …within the legal framework and ethical standards of the pharmaceutical industry (TGA, GMP ) that mitigates risks and reflects its elements in the global Compliance ... are committed to achieving commercial growth and market expansion. You will lead the Compliance team who embody the Lundbeck behaviours of curiosity, adaptability,… more
- Cipla (Fall River, MA)
- …is responsible for the creation and revision of new and existing GMP , project handle, qualification & validation documents preparation and execution. In this ... leads and manages projects to implement continuous improvement opportunities. Lead and/or support root cause investigations related to performance trends… more
- Cipla (Reid, WI)
- …Specialist is responsible for the creation and revision of new and existing GMP batch production records as well as SOP's. In this role the Documentation ... leads and manages projects to implement continuous improvement opportunities. Lead and/or support root cause investigations related to performance trends… more
