Analytical Scientist

Piramal Pharma•Riverview, MI

13h

About The Position

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking an Analytical Scientist to join its Analytical Chemistry team. The role focuses on developing and validating analytical methods, primarily using HPLC and GC, for use by Quality Control and Process Development. The Analytical Scientist also supports manufacturing operations through testing of raw materials, intermediate and final products, and cleaning samples. The role includes assisting with laboratory instrumentation maintenance and calibration, maintaining the QC laboratory and its inventories, and ensuring accurate, timely testing and complete documentation. Laboratory records and test documentation must be maintained appropriately and verified by a second member of the quality group.

Requirements

Meet one of the following education and experience combinations: Ph.D. in Chemistry or Biochemistry and 0–3 years of experience; Master's degree and 3–5 years of experience; or Bachelor's degree and 5–10 years of experience in a related environment.
Knowledge of analytical testing and instrumentation.
Excellent organizational and planning skills.
Strong written, verbal, and interpersonal communication skills.
High attention to detail.
Demonstrated strong analytical skills and the ability to work independently against multiple deadlines.
Proficiency with Microsoft Office Suite and industry-related software.

Responsibilities

Develop accurate, precise, and specific analytical methods for the Quality Control and Process Development departments, primarily using HPLC and GC.
Document method development in appropriate notebooks and prepare PPS-Riverview test methods and supporting laboratory documentation.
Validate analytical methods used to test raw materials, intermediate products, final products, and cleaning samples.
Develop validation protocols and assess assay validation data elements in accordance with current USP and other regulatory requirements.
Perform validation protocols as written, document results in comprehensive validation reports, and make necessary changes to existing documents based on report findings.
Assist in maintaining and calibrating laboratory analytical instrumentation, including HPLC and GC, and keep accurate records of those activities.
Support manufacturing operations by testing raw materials, intermediate products, final products, and cleaning samples, providing accurate and timely results.
Assist with QC laboratory maintenance, routine housekeeping, glassware cleaning, and maintaining appropriate inventories of supplies and chemicals.
Document sample preparation, equipment setup, and test results in laboratory notebooks or appropriate test record forms.
Maintain laboratory log sheets and records for equipment use, calibration and maintenance, reference standards, QC chemicals, and retention samples.
Ensure laboratory documentation is complete and verified by a second member of the quality group.