The Compliance Specialist CMC, Quality Assurance

SGS Consulting; Boston (MA); On-site; USD 52,000 - 78,000; Full time

Job summary

SGS Consulting in the Boston area is seeking a laboratory support candidate to assist the extended science team with daily cell culture work and metabolite analysis.

Responsibilities include preparing media, collecting samples, running assays, and documenting results; no formal degree is required, but hands-on lab experience is valued.

Qualifications

• Cellular therapy laboratory experience required.
• Knowledge of quality control and maintaining accurate batch records.
• Knowledge or experience with bioreactor systems.
• Knowledge or experience with performing metabolite assays.
• Knowledge of immuno‑fluorescent assay and microscope imaging systems.
• Experience with mRNA handling and analysis of qPCR results.
• No specific qualification is required.

Responsibilities

• Formulating and preparing large batches of cell culture media
• Provide group support with media exchanges on a daily basis
• Collect metabolite samples from ongoing lots on a daily basis
• Perform metabolite assays and analyze results on a daily basis, compile and create reports on a weekly basis
• Collect and prepare cell culture samples for RNA extraction, qPCR, ddPCR and immunostaining on a weekly basis
• Maintain accurate records and assist team scientists with recording experimental data

Skills

Cellular therapy laboratory experience

Quality control and batch records

Bioreactor systems

Metabolite assays

Immunofluorescent assay & imaging

mRNA handling & qPCR analysis

Job description

Job Responsibilities

Provide additional support for the extended science team by:

• Formulating and preparing large batches of cell culture media
• Provide group support with media exchanges on a daily basis
• Collect metabolite samples from ongoing lots on a daily basis
• Perform metabolite assays and analyze results on a daily basis, compile and create reports on a weekly basis
• Collect and prepare cell culture samples for RNA extraction, qPCR, ddPCR and immunostaining on a weekly basis
• Maintain accurate records and assist team scientists with recording experimental data

Skills

• Cellular therapy laboratory experience
• Knowledge of quality control and maintaining accurate batch records
• Knowledge or experience with bioreactor systems
• Knowledge or experience with performing metabolite assays
• Knowledge of immuno‑fluorescent assay and microscope imaging systems
• Experience with mRNA handling and analysis of qPCR results

Education/Experience

No specific qualification is required.