QC Associate Bioassay & Molecular Biology

JMD Technologies Inc.

Norwood (MA)

On-site

USD 41,000 - 55,000

Part time

16 hours ago
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Job summary

JMD Technologies Inc. is seeking a QC Associate for Bioassay and Molecular Biology to support cGMP testing of raw materials, drug substances, and finished products in a regulated lab environment.

The role emphasizes molecular biology, cell-based assays, and protein analysis while assisting method qualification and compliance. The successful candidate will perform mammalian cell-based potency assays, qPCR, ELISA, and protein analyses, troubleshoot methods, and help maintain SOPs and regulatory

Qualifications

  • BA/BS degree in a STEM discipline with 3-5 years of experience in a cGMP laboratory environment.
  • Hands-on experience with mammalian cell culture, cell-based and potency assays, molecular biology, ELISA, and protein analysis.
  • Experience with aseptic techniques, biological safety cabinets, reagent preparation, and small-volume pipetting.

Responsibilities

  • Execute QC molecular biology and bioassay methods, including mammalian cell-based potency assays, qPCR, sequencing, ELISA, and protein analysis.
  • Troubleshoot analytical methods, equipment, and assay performance; support method transfers and qualification activities.
  • Perform laboratory support activities including reagent preparation, equipment maintenance, logbook review, and aseptic laboratory practices.
  • Prepare and maintain SOPs, protocols, reports, and quality records while ensuring cGMP documentation and regulatory compliance.
  • Support investigations, change controls, CAPAs, audits, training, and continuous improvement initiatives.

Skills

Mammalian cell culture
qPCR
ELISA
Protein analysis
Bioassay methods
Assay troubleshooting

Education

Bachelor's degree in STEM

Tools

Laboratory equipment calibration
BSC aseptic technique

Job description

Title: QC Associate Bioassay & Molecular Biology

Employment Type: Contract

Status: Accepting Candidates

About the Role

Support cGMP quality control testing of raw materials, drug substances, and finished products in a regulated laboratory environment. The role focuses on molecular biology, cell-based assays, and protein analysis while supporting method qualification and laboratory compliance.

Key Responsibilities
  • Execute QC molecular biology and bioassay methods, including mammalian cell-based potency assays, qPCR, sequencing, ELISA, and protein analysis.
  • Troubleshoot analytical methods, equipment, and assay performance; support method transfers and qualification activities.
  • Perform laboratory support activities including reagent preparation, equipment maintenance, logbook review, and aseptic laboratory practices.
  • Prepare and maintain SOPs, protocols, reports, and quality records while ensuring cGMP documentation and regulatory compliance.
  • Support investigations, change controls, CAPAs, audits, training, and continuous improvement initiatives.
Qualifications
  • BA/BS degree in a STEM discipline with 3-5 years of experience in a cGMP laboratory environment.
  • Hands-on experience with mammalian cell culture, cell-based and potency assays, molecular biology, ELISA, and protein analysis.
  • Experience with aseptic techniques, biological safety cabinets, reagent preparation, and small-volume pipetting.
  • Familiarity with laboratory equipment calibration and maintenance and analytical method development or qualification.
  • Working knowledge of relevant FDA, EU, and ICH guidelines, with the ability to work effectively in a fast-paced, cross-functional environment.
Compensation:
  • $30-$40/hr, based on experience and level.
  • Final compensation within the posted range will depend on qualifications, experience, and interview results.
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