- Merck & Co. (Durham, NC)
- …excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director, External Manufacturing Operations will also assist in ... Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance :-Achieve compliance… more
- Eisai, Inc (Exton, PA)
- …difference. If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading ... close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also… more
- Insmed Incorporated (San Diego, CA)
- … lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take ... for Millennials™, and Best Medium Workplaces™ lists.OverviewLead Analytical Development Operations function to build out the process development support testing… more
- Merck & Co. (Rahway, NJ)
- …and supply our critical medicines and vaccines around the world.External Manufacturing Operations Associate Director (Ops AD), in partnership with the respective ... boundaries and ground rules for engagement with the EPs, while ensuring compliance /quality readiness of these suppliers at all times through the implementation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Associate Director Global Medical Affairs Oncology (GMA), under the direction of ... the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and… more
- Merck & Co. (Rahway, NJ)
- …US and WW regulations, company policies and Standard Operating Procedures.The Associate Director, Business Insights and Analytics (BI&A), is responsible for ... GCS performance Delivering tools and solutions for digital visualizations of KPIsThe Associate Director, BI&A, will: Execute solutions to business needs by designing… more
- Merck & Co. (Durham, NC)
- …responsible for the development, management, and growth of our warehousing and logistics operations , both on the main campus as well as off-site (3rd party) storage ... or supporting strategic projects designed to improve overall warehouse operations and efficiency.- Additional responsibilities will include qualification support of… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist/Sr Principal ... include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the ... activities as well as congress activities. The position serves as a functional lead on cross functional launch planning and other strategic initiatives for Oncology… more
- Merck & Co. (San Francisco, CA)
- …data-driven decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead , the Associate Director, DSCS Digital Project Manager, will be ... Job Description Position Description: Associate Director, DSCS Digital Implementation Project ManagerWithin the...with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on… more
- Merck & Co. (Rahway, NJ)
- …a Technical Lead , you will report into Director, Chemical Technical Operations , External Manufacturing API Technology, and play a pivotal role in managing the ... mitigate risks, and continuously enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve… more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control/QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am ... EST - 4:30 pm EST.The Document Control/QA Associate I will report directly to the QA/QC Director.This position is responsible to actively participate in the Repligen… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Lead Maintenance Technician is responsible for providing equipment troubleshooting and maintenance ... support to VMF Operations areas (sterile supply, weigh/dispense, media, stabilizer/prep, thaw/pool, filling,...satisfactorily perform all types of industrial mechanical work as assigned. Lead the shift group of mechanics and serves as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Rahway, NJ)
- …SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw ... process development, and seamless technology transfer to commercial sites.The SSO Operations Specialist will provide hands on assistance for daily production… more
- Merck & Co. (North Wales, PA)
- …execution and conduct of clinical trial(s).Serves as the Clinical Trial Team lead . Leads and directs teams in key study planning, development, and execution ... and vendor management team . Review and provide clinical operations input into relevant clinical documents such as the...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: ... listings, SAP, Data Management plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in… more
- Merck & Co. (Rahway, NJ)
- …that ensure compliance with GxP (as applicable) and other regulatory requirements. Lead the operation of the site BAS and HVAC control systems. Manage the ... performance indicators (KPIs) for HVAC system reliability, energy efficiency, and compliance . Lead root cause analysis and corrective/preventive actions (CAPA)… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.The… more
- Takeda Pharmaceuticals (Boston, MA)
- …proactively assess the needs for functional processes and system enhancements + Lead the development of internal functional processes and training and ensure ... monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plans + Engage with CPMQ… more
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