• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …research areas centered around rare diseases and immune disorders. Job Summary The GMP Quality Assurance Internship is a program that provides training for the ... will allow them to dive into different functions of GMP QA Department such as Audit, Quality Management System,...into the regulated environment. We are currently seeking a GMP Quality Assurance Intern for the year starting in… more
    HireLifeScience (03/12/24)
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  • Merck & Co. (Rahway, NJ)
    …development activities, compliance investigation, change management and the authoring of GMP documentation in any of our enabling facilities . Supported Areas ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey.… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (Rahway, NJ)
    …Small Scale Organics (SSO) Pilot Plant is a Good Manufacturing Practices ( GMP ) facility within the Process Research and Development (PR&D) organization which enables ... operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other staff in the pilot plant… more
    HireLifeScience (03/26/24)
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  • Ampcus, Inc. (North Potomac, MD)
    …Supervise the purification scale up of protein drug products into GMP manufacturing Utilizing monoclonal antibody purification process platform and applying the ... techniques Develop, optimize, and scale up protein purification processes for GMP manufacturing Demonstrate expert knowledge of protein purification and analysis… more
    JobGet (03/01/24)
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  • Merck & Co. (Rahway, NJ)
    …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. ... operations, process development activities, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of our… more
    HireLifeScience (03/24/24)
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  • Merck & Co. (Rahway, NJ)
    …Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of oral solid dosage, sterile, and specialty dosage ... feedback on product and process development. - These roles require adherence to GMP procedures, strong attention to detail in completing GMP documentation,… more
    HireLifeScience (02/28/24)
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  • Merck & Co. (Rahway, NJ)
    …molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice ( GMP ) clinical supply manufacturing facility in Rahway, New Jersey.The Process ... level will serve as a leader in the FLEx Oral Solid Dosage GMP Clinical Manufacturing facility. --This role will support formulation and process development,… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Rahway, NJ)
    …molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice ( GMP ) clinical supply manufacturing facility in Rahway, New Jersey.The Process ... the Sr. Specialist level will serve as a leader in the FLEx Sterile GMP Clinical Manufacturing facility. As the facility is nearing the completion of its'… more
    HireLifeScience (03/23/24)
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  • Catalent (St. Petersburg, FL)
    …employees including, but not limited to orientation, SOPs, corporate policies, annual GMP refresher training, and other GMP related training.The RolePerforms ... and entering curricula and entering training data per employeeTracks and monitors GMP training using manual and automated systems. Individual will be responsible for… more
    HireLifeScience (03/18/24)
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  • Merck & Co. (Rahway, NJ)
    …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. ... activities, compliance investigation, change management and the authoring of GMP documentation in any of our enabling facilities.Additional Supported AreasAs… more
    HireLifeScience (03/13/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system, ... Issuance of batch related documentation and labels in support of GMP manufacturing. Reconcile GMP documentation following document lifecycle requirements.… more
    HireLifeScience (01/09/24)
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  • Catalent (Harman, WV)
    …and timely resolutionResponsible for and administers the CAPA Tracking System for general GMP use and internal audits. Track the timely completion and extension of ... manufacturing campaignsMaintain databases and systems used for tracking various GMP manufacturing associated support activitiesAssists with the generation and/or… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (Rahway, NJ)
    …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. ... process development activities, support compliance investigations/change management, and author GMP documentation in any of our enabling facilities.Additional Supported… more
    HireLifeScience (03/15/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …culture Requirements High School Diploma (or equivalent) required Minimum 8 years of GMP experience as an operations associate, with 3 years of CAR-T GMP ... required with High School Diploma Minimum 6 years of GMP experience as an operations associate, with 2 years...as an operations associate, with 2 years of CAR-T GMP experience with Associates Degree in technical discipline: Engineering,… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (Durham, NC)
    …operable.Responsible for performing assignments in conformance with appropriate Regulatory ( GMP 's) and department Standard Operating Procedures which assure the ... activities are carried out in accordance with established safety, GMP , and calibration/maintenance procedures.Facilitates contractors by obtaining bids, review… more
    HireLifeScience (02/28/24)
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  • Spectraforce Technologies Inc (Marlborough, MA)
    …testing support for Client cell therapy products. Looking for strong GMP background with method validation and quality control testing experience. Essential ... including drafting technical protocols, reports and troubleshooting. * Execute GMP analytical assays such as Immunofluorescence, Flow Cytometry, PCR, Viability,… more
    JobGet (03/03/24)
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  • Merck & Co. (Rahway, NJ)
    …independent review and approval of documentation to support Good Manufacturing Practice ( GMP ) - clinical supply API manufacture, testing, release, and maintenance in ... manufacturing in a complex, clinical supply development. - Review and/or approve GMP documents. Ensure all API (including new modalities) are manufactured in… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Durham, NC)
    …reviews automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety.Assisting in the development and review and approval of ... department SOPs and other site GMP SOPs related to automation and digital activities and...and troubleshooting in compliance with system life cycle (SLC), GMP , Data integrity, safety, and environmental regulations. Provides client… more
    HireLifeScience (03/22/24)
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  • Catalent (San Diego, CA)
    …will be performed in compliance with company standard operating procedures (SOPs) and GMP regulations, as appropriate. This is a full-time position: Monday - Friday, ... with services that include analytical development, pre-formulation testing, formulation development, GMP manufacturing and stability storage and testing as well as… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    …Research Laboratories, our company's Manufacturing Division, Animal Health and GWES. The system is GMP and monitors areas and equipment that are both GMP and ... and the ability to understand, update and implement changes to the GMP system.Ability to problem solve/troubleshoot, with knowledge of root cause analysis.Experience… more
    HireLifeScience (03/20/24)
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