Senior QC Analyst: cGMP Biotech Testing & Validation

Lonza Group Ltd.

Portsmouth (NH)

On-site

Confidential

Full time

12 days ago
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Benefits offered by this job

Medical, dental and vision insurance
Paid time off (PTO)
Global benefits program

Job summary

Lonza Group Ltd. Portsmouth, NH, is seeking a QC professional to perform advanced release testing, method validation, and data review within a regulated biomanufacturing environment.

The role requires 3–4+ years in QC testing, strong analytical skills, and experience with LIMS and quality systems. A Bachelor’s degree in Biochemistry or Biology is required, Master’s degree preferred. On-site schedule Monday–Friday, 8:00 AM–5:00 PM.

Qualifications

  • 3–4+ years in QC laboratory under cGMP/regulatory testing.
  • Experience with cell culture and immunoassays.
  • Knowledge of GDP and good documentation practices.

Responsibilities

  • Execute advanced cGMP release testing using flow cytometry, ELISA, PCR.
  • Lead assay transfers, qualifications and validation protocols.

Skills

Flow cytometry
Cell culture
PCR assays
GDP & QA awareness
Data review

Education

Bachelor’s degree in Biochemistry/ Biology
Master’s degree preferred

Tools

LIMS
TrackWise

Job description

Lonza Group Ltd. Portsmouth, NH, is seeking a QC professional to perform advanced release testing, method validation, and data review within a regulated biomanufacturing environment.

The role requires 3–4+ years in QC testing, strong analytical skills, and experience with LIMS and quality systems. A Bachelor’s degree in Biochemistry or Biology is required, Master’s degree preferred. On-site schedule Monday–Friday, 8:00 AM–5:00 PM.

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