Analytical Scientist II: Method Development & Validation

Piramal Pharma Ltd; Lexington (KY); On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions in Lexington seeks an Analytical Scientist II to perform complex testing of pharmaceutical materials and finished products. You will develop and transfer test methods for strength, impurities, and identity, using HPLC, GC, KF, and dissolution techniques under supervision.

The role requires experience with potent materials, regulatory knowledge, and strong documentation skills. Collaboration with clients and cross-functional teams is expected to ensure compliance and

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 with HPLC, GC, KF and dissolution techniques.
• Knowledge of GMPs and regulatory requirements in the pharmaceutical industry.
• Demonstrated proficiency approaching solving scientific problems.
• Proficiency with analytical instrumentation and data interpretation.
• Good interpersonal and written communication skills.

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 transfer/verification/validation of test methods for strength, impurities, identity, and dissolution using HPLC, GC, dissolution, KF, spectroscopy, and traditional testing.
• Recognizes and reports out-of-specification or unexpected results and non-routine analytical problems; recommends solutions.
• Maintains and troubleshoots analytical instrumentation as needed.
• Communicates results clearly by documenting testing and analysis; may interact with clients.
• Prepares and assists in filing regulatory documents in support of internal projects and may provide communications with outside departments, 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 problem solving

Interpersonal communication

Attention to detail

Education

BS/MS/PhD in Chemistry/Biochemistry/Pharmaceutical Science

Tools

HPLC

GC

KF

Dissolution

Job description

Piramal Pharma Solutions in Lexington seeks an Analytical Scientist II to perform complex testing of pharmaceutical materials and finished products. You will develop and transfer test methods for strength, impurities, and identity, using HPLC, GC, KF, and dissolution techniques under supervision.

The role requires experience with potent materials, regulatory knowledge, and strong documentation skills. Collaboration with clients and cross-functional teams is expected to ensure compliance and