- Merck & Co. (Rahway, NJ)
- …Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Sterile Operations Equipment Operation Engineer will serve as a primary operations ... to the Sterile Production Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply.Once the facility is operational, duties will… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Associate Specialist - Operations Support The Enabling Facilities (EF) group within the Chemical Engineering Research & ... degree of technical and project management responsibility.The Associate Specialist - Operations Support position will report to the...Support position will report to the Associate Director, Engineering and will be a member of the EF… more
- Merck & Co. (North Wales, PA)
- …for efficacy, dosing, safety profiling and adverse events. The data collected from Clinical Trials are used to support drug applications and regulatory ... relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial Data Integrations,… more
- Merck & Co. (Rahway, NJ)
- …a highly motivated individual to work in a fast-paced job that provides operations experience and a strong understanding of engineering fundamentals. The MACS ... Operations Specialist position will report to the Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within the CAR-T process operations (ie component preparation manufacturing, MFG support operations , Mock cell, and CAR-T process) according to standard ... responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing ... an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Operations Associate (2nd Shift) as part of the Technical Operations team… more
- Merck & Co. (Rahway, NJ)
- …is responsible for interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and exploring ... and speed in the execution of the Company's pipeline. This role may support facility operations , support compliance investigations/change management, author… more
- Merck & Co. (Rahway, NJ)
- …and validation; and, design control and risk management techniques to positively support and influence clinical and commercial combination product development ... your leadership.Remain current in relevant worldwide regulatory guidance and standards.Lead/ support /oversee clinical supplies production with respect to device… more
- Merck & Co. (Rahway, NJ)
- …coordinating maintenance activities around processing activities to support reliable facility operation .#EBRG#Vetjobsautomationjobs#EligibleforERPNOTICE FOR ... Job DescriptionThe Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual… more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... (PCS), Upstream Process Development (UPD) and Downstream Process Development & Engineering (DPDE). This job posting covers opportunities for all three functional… more
- Merck & Co. (Rahway, NJ)
- …(LM/SM/Vaccine), process development, product introduction, commercialization, and Manufacturing ( clinical and commercial).-Extensive Experience in Information and ... product (LM/SM/Vaccine), process development, product introduction, commercialization, and Manufacturing ( clinical and commercial).-Extensive Experience in Information and Operations… more
- Merck & Co. (North Wales, PA)
- …a key collaborator with internal and external stakeholders including Statistics, Clinical Research, Regulatory, Observational Research, Clinical Safety and PK/PD ... operational challenges that require strategic solutions, resulting in improved Clinical Study Report and filing completion timelines worldwide.Lead development of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …inspection/release of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP ... quality and operations counterparts that include Manufacturing Operations , Quality Assurance, Engineering and Validation, Quality...a minimum of 2 years of experience with quality support in clinical manufacture or NPI is… more
- Insmed Incorporated (Bridgewater, NJ)
- …will have responsibility for the management of API/Intermediate/RSM manufacturing operations at Insmed's CMOs including tech transfer, process optimization, ... clinical /commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy. Remote (only in corp. office for purposeful… more
- Merck & Co. (North Wales, PA)
- …is responsible for the design and maintenance of statistical databases that support multiple stakeholder groups which include clinical development, outcomes ... programming activities for multiple and/or large/complex late stage drug/vaccine clinical development projects.- Accountability predominantly includes the development and… more
- Merck & Co. (Rahway, NJ)
- …controls and automation activities throughout the facility.-Primary Responsibilities:Provide process support for clinical manufacturing and R&D processes while ... capital projects, work to design, install, and qualify new equipment to support GMP clinical production. -Execute and develop appropriate system validation,… more
- Merck & Co. (Rahway, NJ)
- …is responsible for the design and maintenance of statistical databases that support multiple stakeholder groups which include clinical development, outcomes ... programming activities for multiple and/or large/complex late stage drug/vaccine clinical development projects.- Accountability predominantly includes the development and… more
- Merck & Co. (North Wales, PA)
- …is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes ... This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... areas: Process Cell Sciences (PCS), Upstream and Downstream Process Development & Engineering . The latter two together form our Biologics' Process Development (BPD)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Job SummaryThis position is responsible for clinical label development support for all Daiichi-Sankyo led clinical ... Program Managers to identify and meet delivery dates for clinical labels to our CMO's and internal packaging sites...our CMO's and internal packaging sites for GMP processing operations . This position will work with a label translation… more
