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Merck
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West Point, Pennsylvania
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). Responsibilities may include serving as a vendor manager, defining and implementing process with vendor ... throughout the business in Research & Development, Information Technology, Quality, Regulatory in pursuit of
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Merck
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West Point, Pennsylvania
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Product for all large molecules. This leader is expected to contribute to ongoing business process ... leadership and the product/process sciences and engineering. The incumbent will have broad, experience-based
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Merck
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West Point, Pennsylvania
...
maintain and develop strong working relationships with network leaders and progress our systems and process ... operational readiness / risk mitigation for clinical MDCP operations in support of current and future MDCP
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Merck
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West Point, Pennsylvania
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maintain and develop strong working relationships with network leaders and progress our systems and process ... execution of program strategies, improvement initiatives, ensuring operational readiness / risk mitigation
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Merck
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West Point, Pennsylvania
...
impact on our business operations and ultimately, patient lives.
**Key Responsibilities ... solutions which deliver maximum business value.
Ensure that Content Management Digital Solutions are
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Merck
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West Point, Pennsylvania
...
evaluations within and across multiple projects.
Influence the regulatory toxicology landscape through ... multidisciplinary environment within the Pharmaceutical Industry, Regulatory Agencies, or Academic Institutions
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Merck
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West Point, Pennsylvania
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diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process ... facility improvements and troubleshoot process equipment to ensure reliable, compliant and efficient
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Merck
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West Point, Pennsylvania
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, clinical candidate selection, starting clinical dose, assessing drug interaction risk and contributing to regulatory filings.
As a member of the DMPK Leadership team, the Executive Director will contribute to
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Merck
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West Point, Pennsylvania
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supplying quality product at a competitive cost consistent with our Company's Regulatory Agency, and State ... (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right
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Merck
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West Point, Pennsylvania
...
business requirements.
Demonstrate an eagerness to learn drug discovery & development processes and regulatory requirements as necessary to solve problems.
Commit to IT infrastructure optimization
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Merck
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West Point, Pennsylvania
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architecture - ingest, process, make data analytics ready and deliver data to stakeholders
Has overview ... architectural design patterns
Ensure ongoing compliance with regulatory safety, GMP and Validation
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Merck
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West Point, Pennsylvania
...
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Business Enterprise Architecture (BEA), Business Process Modeling, Data Management, Data Modeling ... , Vaccines, safety, and process and analytical R&D efforts. The ideal candidate will possess a deep
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Merck
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West Point, Pennsylvania
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manufacturing sites. It generates product and process knowledge required for approval, launch, and life cycle ... oversight to Vaccines and Biologics sterile product and process design, development, characterization
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Merck
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West Point, Pennsylvania
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risk assessment activities as well as perform in silico assessments to characterize mutagenic potential ... is seeking an office-based scientist with expertise in impurity risk assessment. A core
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Merck
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West Point, Pennsylvania
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generate reports to be shared with internal partners or regulatory agencies
Strong communication and ... to business operations, in which case you may not be offered employment, or your employment could be
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Merck
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West Point, Pennsylvania
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/Downstream Process Development, Formulations, Global Clinical Supply, CMC Regulatory, Quality, and Commercial ... .
Support Quality by Design (QbD) activities and lead discussions on process and analytical risk assessment
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Merck
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West Point, Pennsylvania
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_ and in vivo assay capabilities
Access to robust historical controls slide archive and data ... (e.g., magnetic resonance imaging)
Develop novel biomarkers and predictive models to de-risk
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Merck
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West Point, Pennsylvania
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-marketed CMC regulatory submissions.
Lead strategic initiatives within departmental and cross ... face-to-face meetings, then your employment may pose an undue burden to business operations, in which
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Merck
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West Point, Pennsylvania
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practices and trends, communicate and drive improvement
Establishes business process baseline costs ... compliance and reliability for general utilities including compressed air, process compressed gases, chilled
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Merck
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West Point, Pennsylvania
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, packaging process and controls and packaging operation.
Under general scientific and administrative ... of potential risk to business success and generate gap analysis.
Significant experience with
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Merck
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West Point, Pennsylvania
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appropriate risk assessments, and support regulatory filings including INDs/IMPDs and NDAs
Is expected to ... development and technology transfer experience including the use of risk assessment and process capability
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Merck
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West Point, Pennsylvania
...
professional development.
Properly document protocols and findings, author preclinical regulatory ... pose an undue burden to business operations, in which case you may not be offered employment, or your
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Merck
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West Point, Pennsylvania
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Product for all large molecules. Associate Director is expected to contribute to ongoing business process ... management leadership and the product/process sciences and engineering. The incumbent will have broad
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Merck
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West Point, Pennsylvania
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assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify and ... /biomarker collection processes. Applies thorough knowledge of GCP, ICH guidelines and regulatory
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Merck
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West Point, Pennsylvania
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, and closing out change controls for automation related corrective actions and continuous improvement ... , regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to
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Merck
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West Point, Pennsylvania
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parameters, performance parameters, operating ranges, in-process controls. Drive and influence process ... provides the technical process leadership and laboratory capabilities for late stage and commercial drug
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Merck
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West Point, Pennsylvania
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Assurance and Regulatory groups and provides technical insights and support for our portfolio of projects ... enable process improvement and optimal workflows.
**Responsibilities include, but are not limited
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Merck
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West Point, Pennsylvania
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SDLC and change controls for a GMP regulated process/system
**Education Requirements ... Point Digital Manufacturing Operations organization will be responsible for the manufacturing process
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Merck
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West Point, Pennsylvania
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to deliver the best science in the process and product will be a key responsibility. Applicants must ... characterization, process development, formulation development, method qualifications and transfers.
Apply
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Merck
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West Point, Pennsylvania
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Job Description
Vaccines and Advanced Biotechnologies (VAX) Process R&D is responsible ... stages. We are part of the Process R&D organization, which enables modality-agnostic DS/DPI process
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