Analytical Scientist, Validation

*POSITION 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 Services team. The Analytical Scientist is responsible for the development and validation of new analytical methods, including, but not limited to HPLC and GC.*_To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required: _*• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.• Identify and protect the original technical information as part of the company property.*Key responsibilities. *• Prepare PPS-Riverview test methods and supporting documentation for use in the laboratory.• Validate analytical methods used in the testing of raw materials, intermediate products, final products, and cleaning samples.• Develop validation protocols to assess the necessary features of the test methods. Assesse all data elements required for assay validation as per the current USP and other regulatory requirements. Perform protocols as written and documents the results in the form of a comprehensive validation report and makes any necessary changes to existing documents as a result of report findings.• Assist in the maintenance and calibration of laboratory analytical instrumentation including, but not limited to HPLC and GC. Maintain accurate records regarding the maintenance and calibration activities.• Support manufacturing operations with testing of raw materials, intermediate products, final products, and cleaning samples. The incumbent is expected to operate in a neat and orderly manner and to provide accurate and timely test results.• Assist in the maintenance of the QC Laboratory. In addition to routine housekeeping and glassware cleaning, maintains and appropriate inventory of supplies and chemicals.• Document sample preparation, equipment set-up and test results in Laboratory Notebooks or on the appropriate test record form. Documentation must be complete and verified by a second member of the quality group. In addition, laboratory log sheets, those related to equipment usage, calibration, and maintenance, reference standard inventory, QC chemical inventory, or those related to retention samples will be properly maintained.• Partake in the rotating weekend on-call schedule to support the plant''s 24/7 operations.*EDUCATION/EXPERIENCE. *The successful candidate must meet one of the following education/experience combinations:• Master''s Degree and 0-1 years'' experience; OR• Bachelor''s Degree and 1-3 years'' experience in a related environment.Job Type: Full-timeBenefits:* 401(k)* 401(k) matching* Dental insurance* Employee assistance program* Employee discount* Flexible spending account* Health insurance* Health savings account* Life insurance* Paid time off* Parental leave* Professional development assistance* Referral program* Relocation assistance* Tuition reimbursement* Vision insuranceSchedule:* 8 hour shiftAbility to commute/relocate:* Riverview, MI 48193: Reliably commute or planning to relocate before starting work (Preferred)Application Question(s):* Writing Reports* Maintaining Lab NotebookExperience:* HPLC-GC: 2 years (Required)* Analytics: 2 years (Required)* ICH Regulation for Validation: 2 years (Required)* GDP: 2 years (Required)Work Location: One location

Created: 2025-09-06