Scientist II

Job Overview

Scientist II – Business:
Pharma Solutions, Department:
Analytical R&D (ARD),

Location:

Lexington, KY.

The Analytical Scientist II conducts complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods. The role executes proficiency in the development, transfer, verification, and validation of test methods for strength, impurities, identity, and dissolution of pharmaceutical raw materials and finished products utilizing HPLC, GC, dissolution, KF, spectroscopy, and other quantitative analysis techniques under general supervision.

• Conduct complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.
• Execute proficiency in development and transfer/verification/validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, KF, spectroscopy, and traditional wet chemical testing under general supervision.
• Recognize and report out-of-specification or unexpected results and non-routine analytical and product problems; recommend solutions.
• Maintain and troubleshoot analytical instrumentation as needed.
• Clearly and accurately communicate results by creating documentation of the testing/analysis and obtained results. Record and report results of analysis in accordance with prescribed lab procedures and systems. May interact with clients.
• Prepare and assist in filing regulatory documents in support of internal projects and may provide communications with outside departments, corporate sites, agencies, and clients.
• Write SOPs and other instructional documents.
• Clean and organize work area, instrumentation, and testing materials.
• Maintain the necessary compliance status required by company and facility standards.

• BS, MS, or PhD in Chemistry, Biochemistry, or Pharmaceutical Science or related field.

• BS with 2+ years of pharmaceutical industry experience or similar.

• Experience working with potent, cytotoxic materials and parenteral drug products preferred.

• Proficiency using chemistry and analytical instrumental technologies.
• Knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry.
• Demonstrated proficiency in solving scientific problems.
• Proficiency with HPLC, GC, KF, and dissolution techniques.
• Good interpersonal and communication skills (both oral and written).
• Ability to respond to common inquiries or complaints from customers or regulatory agencies.
• Ability to apply mathematical operations to tasks such as determination of test reliability, analysis of variance, and correlation techniques.

• Must use hands to handle, feel, reach, type or operate objects or controls.
• Frequent sitting, talking, reading or hearing.
• Frequent walking or long periods of standing, bending, pushing and pulling.
• Long periods of sitting, typing, or working at a computer station.