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Associate Director Engineering: Electronic Lab Notebook Operations Lead within the Digital Insights team

External
Merck logoMerck · - New Jersey
Full-timeHybridToday
ComplianceData Analysis
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Responsibilities

  • Maintain compliant electronic laboratory notebook and a separate archival system through software lifecycle development
  • Support audit readiness and represent the business owner as appropriate during audits
  • Develop processes to monitor electronic lab notebook health and compliance with local data quality standards and adherence to best practices
  • Collaborate with data governance teams to enforce governance policies
  • Develop communication plans and utilize appropriate channels to inform stakeholders of new features and changes to existing functionality
  • Design, implement and lead a tiered support model for configurational elements within DSCS
  • Collaborate with various strategic initiatives throughout the electronic laboratory notebook program and DDT organization
  • Education Minimum Requirement:
  • Ph.D. in Computer Science, Data Science, Molecular Modeling, Engineering, Chemistry, Physics, Biology, Pharmaceutical Sciences, or a closely-related field with at least 3 years of industrial/pharmaceutical or relevant experience
  • M.S. in Computer Science, Data Science, Molecular Modeling, Engineering, Chemistry, Physics, Biology, Pharmaceutical Sciences, or a closely-related field with at least 5 years of industrial/pharmaceutical or relevant experience
  • B.S. in in Computer Science, Data Science, Molecular Modeling, Engineering, Chemistry, Physics, Biology, Pharmaceutical Sciences, or a closely-related field with at least 8 years of industrial/pharmaceutical or relevant experience
  • Required Experience and Skills:
  • Experience leading cross-functional interactions
  • Experience operating within a regulated environment
  • Utilization of dashboards and other data analytics tools
  • Excellent communication skills, demonstrated creativity, and effective interpersonal skills
  • Ability to deliver complex solutions under compressed timelines in a dynamic environment
  • Motivated to learn new skills, willingness to take on new challenges, and scientific curiosity
  • Preferred Experience and Skills:
  • Experience with one or more drug modalities being developed internally such as small molecule, biologics, vaccines, peptides, drug conjugates
  • Experience with software development lifecycles
  • Experience with operational framewo

Benefits

Health insurance

Additional Information

Job Description We are a global biopharmaceutical leader with a varied portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to inspire our employees as we learn, develop and grow in our careers. We are proud of our over 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development. We are seeking a Senior Scientist to join our Digital Insights team within the Development Sciences and Clinical Supply (DSCS) Digital Technologies organization. Digital is the multiplier that will allow DSCS to deliver better experiments faster, efficient filing and launch, more robust supply chains and higher-confidence decisions across the portfolio. The DSCS Digital Technologies organization is responsible for the invention and application of new digital tools/workflows to support scientists across drug substance development, drug product development and analytical development. We aspire to embed digital technologies into the fabric of DSCS culture to drive transformational impact. The tools that we develop are as varied as the teams developing them, and in this Electronic Lab Notebook Operations Lead role, the successful candidate will leverage their experience in software development lifecycle management and operational excellence to lead the operations of an electronic laboratory notebook and a separate archival system to support our company's pipeline of antibodies, small molecules, peptides, biologics, conjugates, and vaccines. This role will allow the candidate to solve complex operational challenges in supporting the execution of electronic laboratory notebook and related structured data capture systems throughout DSCS. The candidate will be tasked with collaborating with various stakeholders (IT, quality, colleagues throughout DSCS) to advance new versions of the laboratory notebook system through software development lifecycles, evaluate the operational health and compliance of the system, create and utilize communication plans to inform stakeholders of new features, lead various communities of practice supporting aspects of the system, and design, implement and lead a tiered support model for stakeholders within DSCS. This role sits within the Digital Insights team which is working to digitally enable a decision engine for DSCS, by innovating solutions through strong partnership in the domains of Data Science, Data Analysis, Informatics, Multi-Omics, Predictive Science, and Data Engineering.


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