Pharma Analytical Scientist II: Method Dev & QC

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 65,000 - 85,000; Full time

Job summary

Piramal Pharma Limited, a leading pharmaceutical development and manufacturing organization, seeks an Analytical Scientist II to perform complex chemical and physical testing of raw materials and finished products in Lexington, KY. The role focuses on method development, transfer, verification, and validation using HPLC, GC, KF, and dissolution techniques.

The candidate will document results, prepare regulatory filings, and interact with clients as needed, ensuring compliance with lab procedures

Qualifications

• BS, MS or PhD in Chemistry, Biochemistry or Pharmaceutical Science or related.
• 2+ years’ Pharmaceutical industry experience preferred.
• Experience with potent, cytotoxic materials a plus.

Responsibilities

• 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

Skills

Analytical testing

Regulatory GMPs

Data documentation

Communications

Education

BS, MS or PhD in Chemistry, Biochemistry or Pharmaceutical Science or related

Tools

HPLC

GC

KF

Dissolution

Spectroscopy

Job description

Piramal Pharma Limited, a leading pharmaceutical development and manufacturing organization, seeks an Analytical Scientist II to perform complex chemical and physical testing of raw materials and finished products in Lexington, KY. The role focuses on method development, transfer, verification, and validation using HPLC, GC, KF, and dissolution techniques.

The candidate will document results, prepare regulatory filings, and interact with clients as needed, ensuring compliance with lab procedures