- Merck & Co. (Rahway, NJ)
- …responsibility and leadership of internal and external work.The Associate Principal Scientist, Engineering position leverages scientific/technical experience to ... and Skills:Experience performing lab-based research/process development including performing unit operations common in small molecule drug substance process development… more
- Merck & Co. (Rahway, NJ)
- …for Life" Objective. The Global Engineering Solutions (GES) group is seeking an Associate Director of Engineering to manage a significant portion of a very large ... mitigationManaging/ implementing commissioning, qualification, contract administration and project close-out.The Associate Director, Engineering will strive to develop good relationships… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the Associate Director will ... portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case development… more
- Merck & Co. (Rahway, NJ)
- …individual to join our Downstream Process Development and Engineering group as an Associate Principal Scientist.- In this role, you will work with a highly ... and activities include designing and optimization of downstream unit operations such as cell harvest, filtration, chromatography, viral clearance, precipitation,… more
- Merck & Co. (Rahway, NJ)
- …innovation and interest in contributing to upstream and/or downstream bioprocessing.As an Associate Scientist in BPD you will work with a highly collaborative team ... drug substanceIndependently design and conduct experiments for individual unit operations using relevant operational parameters and analytical inputsIntegrate unit … more
- Merck & Co. (Rahway, NJ)
- …goals; others that are directly linked with execution of strategic goals. Operations Target : Drive ongoing procurement activities pursuant to transactions and ... projects not in connection with SMP or strategy creation/execution. This is the "keep the lights on" and it is normally driven by daily/weekly requests from the business and procurement. Typical Activities : Contract review/negotiations; PO issue resolution;… more
- Merck & Co. (Rahway, NJ)
- …support, familiarity with manufacturing batch record reviews and/or operations .Experience with mathematical modeling, theoretical scaling calculations, drug ... substance comparability, scale down establishment, computational fluid dynamics (CFD) modeling, Quality by Design (QbD) and Lean Six Sigma principles. Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA,… more
- Merck & Co. (Rahway, NJ)
- …practices related to clinical supply planning and incorporate them into the team's operations . - Focus on Customers & Patients. - Make rapid, disciplined decisions. ... - Demonstrates Ethics & Integrity. - Required Experience and Skills:- - Bachelor's degree in a scientific, business, or related discipline required , MS/MBA preferred . - At least 8 years of experience in project management . - - At least 5 years of experience… more
- Merck & Co. (Rahway, NJ)
- …disciplines: Knowledge of IAM, Network Security, Endpoint Security, Security Operations , Risk and complianceStrong Grasp of Architectural Principles and ... Technologies: Deep familiarity with modern architectural methodologies including serverless architectures, microservices, and the principles of DevSecOps. Ability to leverage these technologies to deliver innovative and effective security solutions that align… more
- Insmed Incorporated (New York, NY)
- …Insmed.Support research and development programs as requested by R&D, Clinical Operations , and Medical Affairs Departments. This may include trial site ... identification, ongoing recruitment motivation, and issue/problem solving.Provide medical and scientific support to payers, commercial managed markets, and related health care organizations to facilitate access to Insmed's medications for appropriate patients.… more
- Merck & Co. (Rahway, NJ)
- …have 10-15 direct reports composed of experienced, senior and associate scientists.- The successful candidate will effectively partner with Biologics ... and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations , Non-clinical, Clinical, and other functional areasExperience with regulatory… more
- Merck & Co. (Rahway, NJ)
- …have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists.- The successful candidate will effectively partner with ... and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations , Non-clinical, Clinical, and other functional areasExperience with regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in support of Phase I-III clinical studies.Partner with Project Management, Clinical Operations and other functional groups to ensure budgets are always maintained ... for the development and control of functional budget in support of global operations of RD unit.Partner with global function leaders to ensure budgets are always… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations . This position oversees the creation of SAE Flow Plans and may ... activities. This position will interact with global study teams and represent PV operations in global interactions with CS Physicians and other study team members.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …growth. These responsibilities will include management of all day-to-day payroll operations and activities for all US (multi-state) and Canada regions, ensuring ... the candidate possesses significant domain experience with the DSI payroll operations preferred- ADP Vantage Certifications preferred Experience Qualifications- 7 or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business functions include but are not limited to Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative ... Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. The Tech Lead must have the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quantitative value delivered to the business. Works closely with Procurement Operations to integrate the Small Business Administration plan and continuous ... improvement into the sourcing activities. Supports supplier diversity initiatives and promotes sustainability best practices. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.… more
