Scientist (HPLC, Elisa, spectrophotometry)

Pioneer Data Systems, Inc; Andover (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Pioneer Data Systems, Inc is looking for a Scientist in Andover, MA, to develop and validate analytical methods for drug substances. Key responsibilities include conducting experiments, writing regulatory documents, and setting specifications for clinical supplies.

The ideal candidate will have experience with HPLC, ELISA, and GMP understanding, along with a BS degree. This position offers a dynamic environment focusing on innovative drug development.

Qualifications

• Experience with HPLC and ELISA is essential.
• Familiarity with pH measurement and spectrophotometry needed.
• Understanding of GMP regulations is required.

Responsibilities

• Develop and validate analytical methods for drug substances.
• Conduct various experiments for analytical characterization.
• Manage stability samples of development and clinical supplies.
• Prepare regulatory documents for analytical methods.
• Set specifications for clinical supplies release.

Skills

HPLC

ELISA

pH measurement

spectrophotometry

GMP understanding

Education

BS Degree

Job description

Job Title

Scientist (HPLC, ELISA, spectrophotometry)

Responsibilities

• Develop and validate analytical methods necessary for the characterization and release of drug substance and drug product.
• Conduct experiments such as water content, residual solvents, TGA, DSC, particle size, NMR, etc.
• Set up and analyze stability samples of development and clinical supplies.
• Write analytical sections of key ARD and regulatory documents.
• Set specifications for release of clinical supplies and transfer analytical technologies to external vendors and commercial manufacturing sites.

Qualifications

• Experience with HPLC.
• Experience with ELISA.
• Knowledge of pH measurement.
• Experience with spectrophotometry.
• Understanding of GMP.
• BS Degree.

Location

Andover, MA.

Employment Type

W2 (no C2C).