Analytical Scientist II: Method Development & Validation

Piramal Pharma Ltd; Lexington (KY); On-site; USD 60,000 - 90,000; Full time

Job summary

Piramal Pharma Ltd in Lexington, KY is seeking an Analytical Scientist II to perform complex chemical and physical testing of pharmaceutical materials and finished products using validated methods. The role emphasizes method development, transfer, verification and validation for strength, impurities, identity, and dissolution.

You will operate HPLC, GC, KF, dissolution, and spectroscopic techniques, ensure compliance with GMPs, document results clearly, and interact with clients and regulatory

Qualifications

• 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

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

Skills

Analytical instruments

GMP knowledge

Problem solving

Communication skills

Statistical analysis

Education

Bachelor/Master/PhD in Chemistry or related

Tools

HPLC

GC

KF

Dissolution

Job description

Piramal Pharma Ltd in Lexington, KY is seeking an Analytical Scientist II to perform complex chemical and physical testing of pharmaceutical materials and finished products using validated methods. The role emphasizes method development, transfer, verification and validation for strength, impurities, identity, and dissolution.

You will operate HPLC, GC, KF, dissolution, and spectroscopic techniques, ensure compliance with GMPs, document results clearly, and interact with clients and regulatory