Job Description

Scientist

Successful and growing pharmaceutical manufacturer is in need of a qualified Scientist to join their staff for the following responsibilities:

• Validates, verifies and transfers analytical test methods for bulk active drugs, raw materials, and finished dosage forms using instrumentation /techniques such as HPLC, UPLC, GC, GC/Headspace, spectroscopy and titrimetry.
• Uses chromatographic software such as TotalChrom and Empower. Able to troubleshoot instrumentation.
• Writes protocols and reports for method validation, verification and transfer studies.
• Prepares data compilations and reports for internal purposes and regulatory submissions under some limited guidance.
• Conducts all activities in compliance with established regulatory requirements. Has a strong knowledge and understanding of Good Documentation Practices. Understands and complies with safety, General Standard Operating Procedures and policies. Observes safety rules and works safely in the laboratory.
• Provides analytical support for complex analytical investigations.
• Responsible for meeting customer requirements and expectations (internal and external), in full and on time.

Requirements:

• BS in Analytical Chemistry or other Scientific discipline, MS preferred
• 3+ years experience in analytical analysis using analytical instrumentation such as HPLC, UPLC, GC, GC/Headspace, dissolution, and disintegration, spectroscopic and titrimetric techniques.
• Good knowledge of GLP/cGMP regulations, ICH guidelines, and compendial methods is required. Incumbent must possess a good knowledge of separation sciences and modern analytical instruments and must be able to work with others to accomplish project goals.
• Pharmaceutical experience a big plus
• Experience in report writing
• Strong demonstrated experience with Chromeleon or other chromatographic software packages.
• Knowledge of ICH Guidelines.
• Has a strong knowledge and understanding of Good Documentation Practices (GMP)

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