- Merck & Co. (North Wales, PA)
- …guidance of the CIPM Staff Manager & Portfolio Lead, the core responsibility of this senior Project Manager (PM) role will be to manage CMC programs, due ... Job DescriptionGlobal Project and Alliance Management (GPAM) sits in the...levels inside and outside of the organization, specifically with senior management.Sufficient skill levels and technical understanding of CMC… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Senior Scientist, Device Design Control Lead, is a crucial member of our team, responsible for spearheading design control ... concept through launch and post-market surveillance. Key Responsibilities and Activities: The Senior Scientist, Device System - Device Design Control will be… more
- Merck & Co. (Rahway, NJ)
- …talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for ... span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development, including:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by senior staff, playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations. Work is escalated if ... under supervision, with outsourcing to submit appropriate requirements on a project basis. Supports team in generating RFPs and in reviewing proposals… more
- Merck & Co. (Rahway, NJ)
- …early adoption of novel process technologies.Contribute to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams ... to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering… more
- Merck & Co. (Durham, NC)
- …and process improvement projects. Support projects through all phases including project planning, project management and execution.Provide global technical ... and best practices.Assist with complex process investigations, coordinating and supporting project activities under the guidance of project leads.Support… more
- Merck & Co. (Rahway, NJ)
- …of relevant industry knowledge in systematic development, validation, and/or quality control (QC) orMaster's degree in biology, chemistry, biochemistry, or related ... of relevant industry knowledge in systematic development, validation, and/or quality control (QC) orPhD in biology, chemistry, biochemistry, or related science with… more
- Merck & Co. (Rahway, NJ)
- …develop are as diverse as the team developing them, and in this Senior Scientist role, the chosen candidate will leverage fundamental process modeling, machine ... technologies into the fabric of our company process development culture. This Senior Scientist role is a scientific position tasked with solving complex process… more
- Repligen (Clifton Park, NY)
- …project teams.Strong problem-solving skills with mechanical, electrical, and control systems (motors, drives, sensors, packaging lines).Skilled in troubleshooting ... documentation.Collaborate with cross-functional teams on projects, validations, and change controls .Maintain system documentation, equipment drawings, and service logs.Drive continuous… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …related projects. He/she will work with Planners, Manufacturing, Facilities, Quality Control , MSAT, and Engineering to support and improve the planning processes ... partner with PAS-X, SAP, OMP and shop floor planning project teams on master data and system adoption Analyze...maintain site capacity data, future state objectives, and schedule control Implement LEAN & flow in the plant, proactively,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDigital Chemistry, Manufacturing, and Controls ( dCMC ) is a cross-divisional digital transformation initiative that will enable the pipeline by ... the guidance of dCMC Regulatory A uthoring L eadership , t he Senior Specialist, Regulatory Authoring Data Analyst, will o ptimize regulatory authoring processes and… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Digital Chemistry, Manufacturing, and Controls (dCMC) is a cross-divisional digital transformation initiative that will enable ... to regulatory documentation.- Under the guidance of dCMC Leadership, the Senior Specialist, Digital CMC Data Analyst, will support development and implementation… more
- Repligen (Waltham, MA)
- …public company is looking for a strong, experienced, and technically sound Senior Director, Assistant Controller, who will own the Company's accounting processes ... in accordance with GAAP.Ensure timely and accurate financial reporting to senior management and external stakeholders, including quarterly and annual filings (eg,… more
- Merck & Co. (Rahway, NJ)
- …this opportunity is for an individual to join o ur Reseach & Development Division project team as a leader at the detail design phase in preparation for operational ... to write SOPs and technical documents and present to peers and senior management.Analytical skills: Ability to analyze complex data and make recommendations for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …involves deputizing for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, ... CAPA Management Process for the respective business areas.Responsibilities:Leadership and Project Management:Lead the end-to-end quality execution across Medical Affairs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management ... and productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support… more
- Merck & Co. (Rahway, NJ)
- …of DCT deliverables including - robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust ... of tailoring communications to diverse audiences, including governance bodies, senior leadership, team members, and individuals with diverse backgrounds.-… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality ... filling, and freeze-drying operations.Manage IPT budget, resource planning and capital/ project work aligned with site priorities.Who you are:A proven people… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …on the platform process description and collaborate to the global change control process and global investigations.Maintain global program project portfolio and ... based in Raritan, NJ. Role OverviewThis position is a senior technical role in the global MSAT organization. This...MSAT at joint technical and CMC committeesPartner closely with senior Janssen technical team to achieve global alignment on… more
- Merck & Co. (Rahway, NJ)
- …guidance.Escalates potentially significant inspection findings/compliance risks/impact to Company Senior Management.Develops the inspection management plan for each ... trial processes as well as quality management systems and quality control tools.Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority… more
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