Associate Director of GXP Analytics

  • location: Norwood, MA
  • type: Permanent
  • salary: $135,000 - $160,000 per year
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job description

Associate Director of GXP Analytics

job summary:
Reporting to the Associate Director of GXP Analytics, the Principal Process Analytics Engineer will lead the design, development, implementation and support of the process analytics platform and related tools. This position will play a key role in developing our process data strategy, building analytical models and aggregating cross-functional data from manufacturing, supply chain, quality and technical development to support advanced analytics.

Must have strong GXP experience, 3+ years of pharmaceutical experience and strong statistical analysis experience.

 
location: Norwood, Massachusetts
job type: Permanent
salary: $135,000 - 160,000 per year
work hours: 9am to 6pm
education: Bachelors
 
responsibilities:
  • Accelerate and improve our cross-platform data strategy to aggregate multiple sources including manufacturing, equipment, laboratory testing, OSI PI, SAP, environment monitoring, and process development datasets
  • Develop, configure and validate the statistical process analytics models using Statistica and Spotfire
  • Develop logical data models for manufacturing, quality and technical development for process analytics and proactive source and extend the analytics pipeline
  • Partner to collect and develop use cases for real-time operational reporting, statistical analysis and application of machine learning to support product manufacturing and testing
  • Define and implement change management best practices to build and maintain Statistical models in a validated environment
  • Support ad hoc data query needs from platforms including MES, LIMS, ERP and CMMS
  • Assist with the creation of GMP computer systems deliverables including user requirements, system specifications and validation testing scripts
 
qualifications:
  • A bachelor's degree in mathematics, engineering or computer science or master's in data science or equivalent
  • Experience working in Life Sciences, pharma/biotech, specifically related to the shop-floor, process development or QC testing
  • 8-10 years of experience developing, implementing and supporting solutions to enable advanced process analytics
  • Experience with writing complex SQL and understanding of data warehouse architecture, experience with multiple programing languages (Java, C++, etc...) is a plus
  • Understanding of industry technology trends in process analytics, database technologies, machine learning, data integrity and statistical analysis
  • Experience with computer systems validation practices (GAMP)
  • Experience mapping complex processes, understanding data flows and writing detailed functional requirements to support the development of trends/metrics
  • Understanding of industry trends in GMP manufacturing, process and data analytics, data integrity and automation
  • Extensive experience with building predictive/forecasting dashboards
  • Excellent interpersonal and communication skills with ability to work collaboratively within a team of cross functional stakeholders to influence decisions at every level of the organization
  • Self-directed with effective analytical and problem-solving skills. Must be able to drive results on multiple complex assignments simultaneously in a fast-paced environment
  • Experience with building BI dashboards (Looker, Spotfire or Tableau)
 
skills:
  • Data engineering, Pharmaceuticals, SQL, analytics, machine learning, data integrity and statistical analysis. GXP, GMP manufacturing, predictive/forecasting dashboards

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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