Principle Analytical Scientist

POSITION SUMMARY: Piramal Pharma Solutions' HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Principal Analytical Scientist to join our Analytical Chemistry team. The Principal Research Scientist is responsible for the development and validation of new analytical methods, including, but not limited to HPLC and GC. The person will act as a project lead, and is expected to be the main point of contact between the client and the Analytical Services group; in this capacity, they will be responsible for periodically informing clients on the status of their project. The Principal Analytical Scientist is expected to work independently and act as a Subject Matter Expert for all relevant departments in the company. Additionally, the Principal Analytical Scientist will be expected to interact with the other departments of PPS-Riverview (Quality Assurance, Quality Control, Safety, Engineering, Operations, etc.) to ensure that all resources required for developing and approving a project are in place.

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 RESPONSBILITIES.

• Develops analytical methods that are accurate, precise, and specific for use in both the Quality Control department and the Research department. Methods primarily include HPLC and GC but may extend to other testing procedures. Documents the development of the method in the appropriate notebooks for future reference.
• Prepares PPS-Riverview test methods and supporting documentation for use in the laboratory.
• Validates analytical methods used in the testing of raw materials, intermediate products, final products, and cleaning samples.
• Develops 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. Performs 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.
• Assists in the maintenance and calibration of laboratory analytical instrumentation including, but not limited to HPLC and GC. Maintains accurate records regarding the maintenance and calibration activities.
• Supports manufacturing operations with testing of raw materials, intermediate products, final products, and cleaning samples as needed. The incumbent is expected to operate in a neat and orderly manner and to provide accurate and timely test results.
• Takes initiative to identify and correct any weaknesses in the current PPS-Riverview systems.
• Drive improvement projects that are relevant to the Analytical Services and Quality Control groups.
• Assists in the maintenance of the QC Laboratory. In addition to routine housekeeping and glassware cleaning, maintains and appropriate inventory of supplies and chemicals.
• Documents 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.
• Assists in review of peer's data.

EDUCATION/EXPERIENCE.

• The Principal Research Scientist will have a Ph.D. in Chemistry or Biochemistry and ten (10) years' experience, a Master's Degree and fifteen (15) years' experience, or a Bachelor's Degree and twenty (20) years' experience in a related environment.
• Thorough knowledge of analytical instrumentation.
• Thorough knowledge of GMP.
• Ability to work independently and solve problems.

JOB COMPETENCIES.

• 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.).