Analytical Scientist

Piramal Pharma Limited; Riverview, Northern (MI, KY); Hybrid; USD 70,000 - 100,000; Full time

Job summary

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC) in Riverview, Michigan seeks an Analytical Scientist to join the Analytical Chemistry team. The role focuses on developing and validating analytical methods, especially for HPLC and GC, to support QC and process development efforts.

The candidate will document method development, assist in instrument maintenance, and ensure compliance with USP and regulatory requirements.

Qualifications

• 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.).

Responsibilities

• Develop analytical methods that are accurate, precise, and specific for use in QC and Process Development; methods primarily include HPLC and GC.
• Document the development of the method in appropriate notebooks for future reference.
• Prepare PPS-Riverview test methods and supporting documentation for the laboratory.
• Validate analytical methods used in testing of raw materials, intermediates, final products, and cleaning samples.
• Develop validation protocols to assess features of test methods.
• Maintain calibration and maintenance records for laboratory instrumentation, including HPLC and GC.

Skills

Analytical testing

Instrumentation

Organization

Communication

Attention to detail

ChemStation

Education

PhD in Chemistry or Biochemistry

Master's Degree

Bachelor's Degree

Tools

Agilent ChemStation

Job description

Be the First to Apply Division 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

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 document 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.
• Operate in a neat and orderly manner and provide accurate and timely test results.
• Assist in the maintenance of the QC Laboratory. In addition to routine housekeeping and glassware cleaning, maintain an 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.
• Maintain laboratory log sheets, those related to equipment usage, calibration, and maintenance, reference standard inventory, QC chemical inventory, or those related to retention samples.

Education & Experience

• Ph.D. in Chemistry or Biochemistry and 0-3 years’ experience.
• Master’s Degree and 3-5 years’ experience.
• 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.).

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.