- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of concern and either resolve, propose solutions, or bring to the attention of the operations lead of study team lead . Coordinate and liaise with Daiichi ... clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound, on regular basis and ensure… more
- Merck & Co. (Rahway, NJ)
- …global regulatory standards, and identifies opportunities to enhance efficiency and streamline regulatory operations processes. Also take lead or help lead ... Job DescriptionThe regulatory operations senior specialist supports cross-functional or departmental projects related to regulatory operations . This role will… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently. About the PositionAs a Lead Product Manager, you will help execute on our tech strategy through 0-to-1 ... company, including our Medical/R&D, Biometrics, Clinical Program Management, and Clinical Operations teams to help identify solutions to their unique challenges.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for ... at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub...as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation of ... Management -supports Person in Plant (PIP) activities when packaging operations for DSI are in-process. Supports investigational product distribution activities… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking an experienced Associate Vice President (AVP) to lead the delivery and operations of our SAP platform, focusing on the S/4 HANA ... on AWS, supporting critical business functions such as accounting, financial operations , order to cash, logistics execution, manufacturing, quality, and procurement.… more
- Merck & Co. (Rahway, NJ)
- …Overall, proven ability to build a data asset strategy & innovation agenda and lead its execution.Strong business acumen with a keen ability to understand how data ... can be leveraged to inform critical commercial decisions and actions.Proven ability to lead a team in analyzing and assessing the commercial value of data assets.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery ... cross-functional meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and executing Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL ... and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data… more
- Merck & Co. (Rahway, NJ)
- …substance (upstream, downstream, and conjugation) and drug product manufacturing unit operations using a variety of process-modeling tools.-As a potential candidate, ... help with development, commercialization, and troubleshooting of large-molecule unit operations .Using modeling solutions, support process development, process characterization, scale-up,… more
- Merck & Co. (Rahway, NJ)
- …customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... to: - - Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and… more
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's portfolio. Acting ... documents outside of QA. Assure the execution of QA Audit Plans, Lead internal and external audits to assess compliance with regulatory requirements, track… more
- Merck & Co. (Rahway, NJ)
- …changing so we are also seeking to re-imagine and continuously improve our operations and supporting business processes for our valued colleagues across our Company ... New Jersey Site .- This role will support facility operations by provid ing technical guidance and mentoring to...assessments on infrastructure systems , develop work processes and lead efforts to quickly troubleshoot complex utility issues to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director of Data Management (DM) Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with ... experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control and reporting under RBQM Central Statistical Monitoring ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical variables and processes, as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAccountable to lead , manage and ensure that all Contract Manufacturing, Testing and Warehousing ... which include API and drug product manufacturing, packaging and labelling operations , QC testing and release, and distribution for biologics and small-molecules… more
- Merck & Co. (Rahway, NJ)
- …our company's global business units, including Manufacturing, Commercial, Technical Operations , Research and Development, and Corporate Units, by identifying and ... initiatives within the organization's real estate portfolio. This position will lead the team responsible for managing and analyzing data, supporting strategic… more
- Merck & Co. (Rahway, NJ)
- …Infrastructure. This position will be a member of the Research Automation Operations product (Laboratory and Plant) within RIPL. -As Sr. OT Infrastructure ... Specialist, you will lead the definition and implementation of high-level requirements, principles...impact to automation systems with IT driven firewall rule changes. Lead /assist project scopes, define IT and infrastructure deliverables, timelines… more
- Merck & Co. (Rahway, NJ)
- …our Company Manufacturing sites, External Manufacturing, R&D, Quality, Operations , Product Development groups, Regulatory Affairs, Procurement, and suppliers.Key ... that customer/stakeholder needs are the cornerstone of decisions and expectations- Lead technical investigations of medical device and combination product needs for… more
