Specialist I, QC Analytics (Wed-Sat Shift)

ElevateBio
Massachusetts
Workplace: OnsiteFull timeUSD 43 - 57 hourlyFunction: Data Analytics & Business IntelligenceExperience: 3+ yearsEducation: bachelorsSkills: ["Organizational skills","Attention to detail","Ability to work independently","Communication","Collaboration"]

Support product release testing in the QC analytical laboratory at the BaseCamp facility in Waltham, MA. Qualify, write/review protocols, and execute cell and molecular biology assays for gene therapy programs. Draft and review methods and qualification/validation procedures for cellular assays such as flow cytometry, analyze and communicate results, and investigate analytical excursions, deviations, CAPAs, and OOSs. Assist with lab staff training and cross-functional QC timelines.

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ElevateBio
ElevateBio
4 days ago

Specialist I, QC Analytics (Wed-Sat Shift)

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Last checked: 4 hours agoStatus: Live

Job Summary

Support product release testing in the QC analytical laboratory at the BaseCamp facility in Waltham, MA. Qualify, write/review protocols, and execute cell and molecular biology assays for gene therapy programs. Draft and review methods and qualification/validation procedures for cellular assays such as flow cytometry, analyze and communicate results, and investigate analytical excursions, deviations, CAPAs, and OOSs. Assist with lab staff training and cross-functional QC timelines.
Location: Massachusetts
Workplace: Onsite
Employment Type: Full time
Job Function: Data Analytics & Business Intelligence
Seniority: Mid level

Key Responsibilities

  • •Support product release testing in the QC analytical laboratory at the BaseCamp facility in Waltham, MA.
  • •Qualify, write/review protocols, and execute cell and molecular biology assays for gene therapy programs.
  • •Draft and review methods and qualification/validation procedures and reports for cellular assays such as flow cytometry.
  • •Perform routine molecular and cellular analytical tests; review, analyze, and communicate results.
  • •Investigate and review analytical testing excursions including deviations, CAPAs, and OOSs; assist with training and coordinate QC timelines.

Pay and Benefits

Salary: USD 43 - 57 hourly

Key Requirements

  • •Bachelor’s or Master’s degree in a technical discipline (Biology, Chemistry, Microbiology, or related) with 3+ years of experience, or 1+ year with a Master’s degree.
  • •Experience in a GMP QC laboratory setting (preferred).
  • •Experience with techniques such as PCR, Flow Cytometry, immunoassays, and cIEF.
  • •Significant experience with flow cytometry (strongly preferred).
  • •Significant knowledge of GMPs, SOPs, and Quality System processes; experience drafting test methods and qualifications is strongly preferred.
Experience:3+ years
Education:Bachelor's in Biology/Chemistry/Microbiology or related field
Skills:Organizational skillsAttention to detailAbility to work independentlyCommunicationCollaboration
Languages:English
Tech Stack:PCRFlow CytometryImmunoassaysCIEFGMPSOPsLIMSCMMSQMSERP

Company Brief

ElevateBio
Develops and manufactures cell and gene therapies and provides integrated biologics development and manufacturing platforms, partnering with biotech companies to accelerate clinical and commercial production of advanced therapies.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Established Company
Headquarters: Cambridge, United States
Founded: 2017
WebsiteLinkedIn