Scientist II

Job Title:

Scientist II – Pharma Solutions

Department:
Analytical R&D (ARD)

Location:

Lexington, KY

The Analytical Scientist II conducts complex chemical and physical testing of pharmaceutical raw materials and finished products. Executes proficiency in development and transfer/verification/validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution using HPLC, GC, dissolution, KF, spectroscopy, and traditional quantitative analysis.

Directly reports to Associate Director, Analytical R&D.

• 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 quantitative analysis, utilizing HPLC, GC, dissolution, KF, spectroscopy, and/or 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 of work by creating documentation of the testing/analysis and obtained results. Records and reports 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.
• Cleans and organizes work area, instrumentation, and testing materials.
• Maintains the necessary compliance status required by company and facility standards.

• BS, MS or Ph.D. in Chemistry, Biochemistry or Pharmaceutical Science or related fields.
• BS with 2+ years’ 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 approaching 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 such tasks 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.