Industry - Pharma / Biotech / Clinical Research

Category - Operations

Skills - Analytical Chemist/Scientist. Development and Validation of New Methods.

Job Type - Permanent

Job Description :

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 Chemistry 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 :

- 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. 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:

- 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.).

JOB CONDITIONS :

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Demands:

- Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.

- Long periods of standing and walking can be expected in this position.

- This position may require long periods of sitting, typing, computer entry or looking at a computer.

Work Environment:

- Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical /pharmaceutical manufacturing equipment and processes.

- Potential limited exposure to hazardous chemicals.

- Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with these positions.

Contact - Shannon Huver

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