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Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Analytical Scientist
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 Analytical Scientist is responsible for the development and validation of new analytical methods, including, but not limited to HPLC and GC.
Key responsibilities.
- Develop analytical methods that are accurate, precise, and specific for use in both the Quality Control department and the Process Development department. Methods primarily include HPLC and GC but may extend to other testing procedures.
- Document the development of the method in the appropriate notebooks for future reference.
- 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. Assesses 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.
EDUCATION/EXPERIENCE.
The successful candidate must meet one of the following education/experience combinations:
- Ph.D. in Chemistry or Biochemistry and 0-3 years' experience; OR
- Master's Degree and 3-5 years' experience; OR
- Bachelor's Degree and 5-10 years' experience in a related environment.
job competencies.
- 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 (Agilent ChemStation, etc.).