Scientist II

Piramal Pharma•Lexington, KY

About The Position

The Analytical Scientist II, in the Analytical Development Department at Piramal Pharma Solutions’ Lexington location, conducts complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological samples, and stability samples. The role develops and transfers, verifies, and validates test methods for pharmaceutical materials and products, including methods for strength, impurities, identity, and dissolution. Testing is performed using techniques such as HPLC, GC, dissolution, Karl Fischer (KF), spectroscopy, and traditional quantitative or wet-chemical analysis under general supervision. Reporting to the Associate Director, Analytical R&D, the Scientist II documents and reports analytical results in accordance with laboratory procedures and systems, identifies and reports out-of-specification or unexpected results, and recommends solutions to analytical or product problems. The role also maintains and troubleshoots instrumentation, supports regulatory documentation, writes SOPs and instructional documents, keeps the work area and equipment organized, and maintains compliance with company and facility standards. The position may involve interaction with clients and communications with other departments, corporate sites, agencies, and clients.

Requirements

BS, MS, or PhD in Chemistry, Biochemistry, Pharmaceutical Science, or a related field.
For candidates with a BS, 2 or more years of pharmaceutical industry experience or similar experience.
Proficiency using chemistry and analytical instrumental technologies.
Knowledge of pharmaceutical industry 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 to tasks such as determining test reliability and performing 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, transfer, verify, and validate test methods for pharmaceutical raw materials and finished products, including methods for strength, impurities, identity, and dissolution.
Use HPLC, GC, dissolution, KF, spectroscopy, and traditional quantitative or wet-chemical testing techniques under general supervision.
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 results clearly and accurately; record and report analytical results in accordance with prescribed laboratory procedures and systems.
Prepare and assist with filing regulatory documents in support of internal projects, and communicate with outside departments, corporate sites, agencies, and clients as needed.
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.
May interact with clients.