Analytical Scientist II: Method Development & Validation

Piramal Pharma Limited; Lexington (KY); On-site; USD 70,000 - 110,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, KY seeks an Analytical Scientist II to perform complex testing of raw materials and finished products. You will validate and transfer test methods, analyze data, and maintain instruments with supervision.

Strong communication with clients and regulatory teams is required. Qualifications include a BS/MS/PhD in chemistry-related fields or BS with 2+ years of pharma experience; proficiency with HPLC, GC, KF, and dissolution is preferred.

Qualifications

• BS, MS or PhD in Chemistry, Biochemistry or Pharmaceutical Science or related.
• BS with 2+ years’ Pharmaceutical industry experience or similar.
• Experience working with potent, cytotoxic materials and parenteral drug products preferred.
• Proficiency using chemistry and analytical instrumental technologies.
• Knowledge of GMPs and regulatory requirements in pharma.

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 qualitative testing.
• 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.
• 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

HPLC

GC

Dissolution

KF

Spectroscopy

Data analysis

Problem solving

Communication skills

Education

Bachelor's/Master's/PhD in Chemistry or related

BS with 2+ years pharma experience

Job description

Piramal Pharma Solutions in Lexington, KY seeks an Analytical Scientist II to perform complex testing of raw materials and finished products. You will validate and transfer test methods, analyze data, and maintain instruments with supervision.

Strong communication with clients and regulatory teams is required. Qualifications include a BS/MS/PhD in chemistry-related fields or BS with 2+ years of pharma experience; proficiency with HPLC, GC, KF, and dissolution is preferred.