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ElevateBioPosted 2 weeks ago

Senior Manager, Metrology

$150,000–$200,000 year

On-siteWaltham, Massachusetts, United States

Full TimeSenior LevelDoctorate Or Professional DegreeMediumBIOTECH

Job Summary

Provide leadership for assigned duties at ElevateBio's facility, including overall supervision of associates and contractors performing calibrations and various testing activities. Direct group activities, resolve problems with vendors and clients, and track progress toward scheduled workloads while reassigning resources to meet timelines. Review and approve departmental procedures, work orders, and reports; drive systems improvements and generate revised SOPs for the metrology program. Train staff on equipment and procedures, maintain a safe work environment, and identify quality issues to support internal and external audits. Set calibration tolerances and ranges with system owners, ensuring measurement quality, integrity, and traceability while meeting regulatory requirements. Maintain professionalism and multitask to control costs and support cycle time.

Required Qualifications

  • Bachelor's degree and at least 8 years of related experience or Master's degree with at least 6 years of related experience; or a PhD with at least 4 years of experience
  • Experience with Calibrating process, laboratory, packaging, and utility systems instrumentation/equipment in a GMP environment
  • Ability to multitask and always maintain professionalism
  • Strong Microsoft Excel skills
  • Proficient in Microsoft Office products (Outlook, Word, Excel, etc.)
  • Ability to read, understand, and follow SOP, P&ID's and work instructions
  • Strong communication skills in both oral and written reports
  • Reviewing GMP documentation for accuracy and compliance
  • Participating in client, regulatory, and internal audits
  • Have a working knowledge of industry guidelines
  • Experience presenting and defending Calibration Program in Regulatory Audits
  • Ability to stand, walk, bend and stretch for extended period of time
  • Ability to lift 25-50 lbs
  • Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE
  • Ability to perform routine repetitive motions with use of arms, wrists and hands

Desired Qualifications

  • Experience working with Blue Mountain RAM or other CMMS programs preferred

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