Scientist II

Piramal Pharma Ltd•Lexington, KY

About The Position

The Analytical Scientist II conducts complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological samples, and stability samples using internally developed and compendial methods. The role develops and transfers, verifies, and validates analytical test methods for strength, impurities, identity, and dissolution under general supervision. Testing may use HPLC, GC, dissolution, Karl Fischer (KF), spectroscopy, and traditional wet chemical analysis. The Scientist II identifies and reports out-of-specification or unexpected results and non-routine analytical or product problems, recommending solutions. The position also maintains and troubleshoots analytical instruments, documents and reports testing results according to laboratory procedures and systems, and may interact with clients. Additional work includes assisting with regulatory filings, writing SOPs and instructional documents, maintaining an orderly work area, and meeting company and facility compliance standards.

Requirements

BS, MS, or PhD in Chemistry, Biochemistry, Pharmaceutical Science, or a related field.
For candidates with a BS, at least 2 years of pharmaceutical industry experience or similar experience.
Proficiency using chemistry and analytical instrumental technologies.
Knowledge of pharmaceutical quality and regulatory requirements, including pharmaceutical GMPs and descriptive organic chemistry.
Demonstrated proficiency in approaching and solving scientific problems.
Proficiency with HPLC, GC, KF, and dissolution techniques.
Good oral and written interpersonal and communication skills.
Ability to respond to common inquiries or complaints from customers or regulatory agencies.
Ability to apply mathematical operations, including determination of test reliability, analysis of variance, and correlation techniques.

Nice To Haves

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

Responsibilities

Conduct complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological samples, and stability samples using internally developed and compendial methods.
Develop and transfer, verify, and validate test methods for pharmaceutical raw materials and finished products, including tests for strength, impurities, identity, and dissolution.
Use HPLC, GC, dissolution, KF, spectroscopy, and traditional quantitative or wet chemical testing methods.
Recognize and report out-of-specification or unexpected results and non-routine analytical or product problems, and recommend solutions.
Maintain and troubleshoot analytical instrumentation as needed.
Document testing and analysis accurately and record and report results in accordance with laboratory procedures and systems; may interact with clients.
Prepare and assist with regulatory documents for internal projects and may communicate with outside departments, corporate sites, agencies, and clients.
Write SOPs and other instructional documents.
Clean and organize the work area, instrumentation, and testing materials.
Maintain the compliance status required by company and facility standards.