Analytical Scientist: Method Development & Validation

piramalpharma; Town of Riverview (WI); On-site; USD 70,000 - 100,000; Full time

Job summary

Piramal Pharma Solutions' HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Analytical Scientist to join our Analytical Chemistry team. The person will develop and validate analytical methods, including HPLC and GC, for raw materials through final products.

Key responsibilities include method development, documentation, validation per USP and regulatory standards, instrument maintenance, and collaboration with QC and Process

Qualifications

• Experience in analytical method development and validation.
• Experience with HPLC and GC.
• Strong documentation and data integrity knowledge.
• Familiarity with USP and regulatory requirements.

Responsibilities

• Develop analytical methods that are accurate, precise, and specific for QC and Process Development; methods primarily include HPLC and GC.
• Document method development in appropriate notebooks for future reference.
• Prepare PPS-Riverview test methods and supporting documentation for laboratory use.
• Validate analytical methods for raw materials, intermediates, final products, and cleaning samples.
• Develop validation protocols per USP and regulatory requirements; document results.
• Assist in maintenance and calibration of laboratory instrumentation (HPLC, GC).
• Support manufacturing operations with testing of materials, intermediates, final products, and cleaning samples.
• Maintain QC Laboratory by housekeeping, inventory of supplies and chemicals.
• Document sample preparation, equipment setup, and test results with verification.

Skills

HPLC

GC

Method development

Validation

Documentation

Quality control

Instrument calibration

Agilent ChemStation

Education

PhD in Chemistry or Biochemistry

MS in Chemistry or Biochemistry

BS in related field

Tools

Agilent ChemStation

Job description

Piramal Pharma Solutions' HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Analytical Scientist to join our Analytical Chemistry team. The person will develop and validate analytical methods, including HPLC and GC, for raw materials through final products.

Key responsibilities include method development, documentation, validation per USP and regulatory standards, instrument maintenance, and collaboration with QC and Process