Scientist II

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

Job summary

Piramal Pharma Limited in Lexington, KY is seeking an Analytical Scientist II in Pharma Solutions. You will conduct complex chemical and physical testing of pharmaceutical raw materials and finished products, and contribute to development and transfer/verification/validation of test methods for strength, impurities, identity, and dissolution.

This role requires hands-on proficiency with HPLC, GC, KF, dissolution, and spectroscopy, plus strong documentation, communication, and compliance with GMP

Qualifications

• BS/ MS/ PhD in Chemistry or Pharmaceutical Science.

Responsibilities

• Conducts complex chemical and physical testing of pharmaceutical materials and products.
• Develops and transfers/validates test methods for strength, impurities, identity, and dissolution.
• Maintains and troubleshoots analytical instrumentation as needed.
• Writes SOPs and reports results per lab procedures.

Skills

Problem solving

Documentation

Communication

Education

BS in Chemistry

MS in Chemistry

PhD in Chemistry

Tools

HPLC

GC

KF

Dissolution

Spectroscopy

Wet chemistry

Job description

Job Description

Scientist IIBusiness: Pharma Solutions

Department: Analytical R&D (ARD)

Location: Lexington, KY

Location: Lexington, KYJob Description

Business: Pharma Solutions

Department: Analytical R&D (ARD)

Location: Lexington, KY

Job Overview

The Analytical Scientist II conducts complex chemical and physical testing of pharmaceutical raw materials and finished products. Executes proficiency in development and transfer/verification/validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, and identity.

Reporting Structure

Directly reports to Associate Director, Analytical R&D

Key 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

Experience

• 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

Competencies

• Proficiency using chemistry and analytical instrumental technologies
• Knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry.
• Demonstrated proficiency approaching in solving scientific problems
• Proficiency with HPLC, GC, KF and dissolution techniques
• Good interpersonal and communication skills (both oral and written)
• Ability to respond to common inquiries or complaints from customers or regulatory agencies
• Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques

Physical Demands

• Must use hands to handle, feel, reach, type or operate objects or controls
• Frequent sitting, talking, reading or hearing
• Frequent walking or long periods of standing, bending, pushing and pulling
• Long periods of sitting, typing, or working at a computer station