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.
Executes 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
Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems; recommends solutions
Maintains and troubleshoots analytical instrumentation as needed
Clearly and accurately communicates the 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.
Prepares and assists in filing regulatory documents in support of internal projects and may provide communications with outside departments, corporate sites, agencies, and clients.
Writes 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
Requirements
BS, MS or PhD in Chemistry, Biochemistry or Pharmaceutical Science or related
Work Experience
BS with 2+ years' Pharmaceutical industry experience or similar
Experience working with potent, cytotoxic materials and parenteral drug products preferred
Competencies
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
Physical Demands
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
Benefits
Vision insurance
Additional Information
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Job Description
Scientist IIBusiness: Pharma Solutions
Department: Analytical R&D (ARD)
Location: Lexington, KYJob Description
Business: Pharma Solutions
Department: Analytical R&D (ARD)
Location: Lexington, KY
Job Overview
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, and identity.
Reporting Structure
Directly reports to Associate Director, Analytical R&D
Piramalpharma · Lexington