- 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 ... MachinesThe ability to satisfactorily perform all types of industrial mechanical work as assigned. Lead the shift group of mechanics and serves as a role model within… more
- Merck & Co. (Rahway, NJ)
- …and regulatory aspects of combination products.The incumbent must be able to lead cross-functional development teams within DD&T and across our company, and work ... Engineering Leaders, assisting them in navigating their development programs.Primary Responsibilities: Lead and set direction for the device development strategy for… more
- BioAgilytix (Durham, NC)
- …orientation, marital status, religion, age, disability, gender identity, results of genetic testing , service in the military, or any other group protected by ... federal, state, or local law. more
- Aequor (Devers, TX)
- …Months with High Possibilities of ExtensionDescriptionThe Cell Therapy SAP Sourcing Migration Lead is located in Devens, Massachusetts. This role will report to the ... Devens Associate Director, Cell Therapy Site Procurement Lead and will follow the Client Hybrid work schedule...compliance from one ERP System to the other. Data Testing : Act as the designated POC for Procurement User… more
- Merck & Co. (Rahway, NJ)
- …to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing , release, and maintenance in support of our company's clinical supply ... requirements, cGMPs and our company's procedures to assure API manufacturing and testing is in compliance and will gain competency in their responsibilities.-- -… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CCRs), methods, specifications, protocols and reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management, conducts ... federal and local laws Performs validation of analytical methods and release/stability testing for raw materials, IP, FP and ST samples of pilot/pivotal/submission… more
- Insmed Incorporated (San Diego, CA)
- …Development Operations function to build out the process development support testing function within analytical development. Will develop systems and processes to ... facilitate rapid, high throughput testing . As the Sending Unit, will facilitate transfer of...(internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and CDx submission plan for each country/region, both before and after CDx testing , for less complex projects.At the time of implementation of a CDx study/IVDR ... performance evaluation study integration of an assay into clinical testing (before testing ) and once data is...and Switzerland. CDx RA Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory… more
- Merck & Co. (South San Francisco, CA)
- …scientific direction of companion diagnostics (CDx). - Specifically, the Diagnostics Lead will develop and execute diagnostic strategies and interact with various ... plusOther Qualifications:10+ years of industry experience in clinical biomarker testing and CDx development.Deep understanding of scientific concepts, clinical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and sponsor various department… more
- Twist BioScience (South San Francisco, CA)
- …systems, and other enterprise applications using MuleSoft, Workato, and related platforms. Lead technical design sessions, review design and code, and ensure ... teams.Collaborate with business stakeholders to translate requirements into technical solutions. Lead troubleshooting efforts and resolve complex technical issues across… more
- Merck & Co. (Upper Gwynedd, PA)
- …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 ... of the probability of regulatory success together with risk mitigation measures.- Lead development and execution of global product and project regulatory… more
- Twist BioScience (South San Francisco, CA)
- …experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, ... align with our overall manufacturing strategy and business objectives. The Director will lead a team of MES professionals, primarily software developers, who work in… more
- Merck & Co. (South San Francisco, CA)
- …therapy programs from Preclinical Candidate approval through Clinical Pharmacology testing (Phase 1), and clinical Proof-of-Concept (Phase 2).Development of ... therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate… more
- Merck & Co. (Rahway, NJ)
- …to integrate data solutionsStrong Influencing and negotiation skillsAbility to lead , create future state, and deliver resultsDemonstrated ability to develop ... Business Support, CAPA Management, Clinical Supply Chain Management, Clinical Testing , Communications Support, Customer Experience Optimization, Customer-Focused, Databricks Unified… more
- Merck & Co. (Boston, MA)
- …training in a related subspecialtySignificant research experience as lead clinical investigator, specifically experience with investigator-initiated studies, concept ... Material(s):Required Skills:Adaptability, Clinical Development, Clinical Judgment, Clinical Research, Clinical Testing , Collaboration, Communication, Cross-Functional Communications, Cross-Functional Teamwork, Dermatology, External… more
- Merck & Co. (Rahway, NJ)
- …principles, expertise in medical devices and combination product processes, and analytical testing for devices, as well as the ability to enhance the organization's ... product regulations and processes.- It is expected that this role will lead significant investigations or events directly, and mentor and coach their team… more
- BioAgilytix (San Diego, CA)
- …life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of preclinical, clinical, and ... evaluating results. Identify new analytical techniques and technologies and lead their implementation.Review analytical instrument and equipment calibration, qualification… more
- Merck & Co. (North Wales, PA)
- …trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or programming staff assigned to a development ... and provides biostatistical support for drug projects under the supervision of management.- Lead a team of staff assigned to the project as needed.-This includes… more
- Merck & Co. (North Wales, PA)
- …clinical/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring ... Operations, Clinical Outcomes, Clinical Research, Clinical Study Design, Clinical Testing , Clinical Trial Compliance, Clinical Trial Management, Communication, Data… more
