Job Description
Job Description ROUTINE ANALYSIS OF FINISHING PRODUCTS & RAW MATERIAL. TESTING STABILTY SAMPLESUNDER DIFFERENT ICH CONDITIONS. PERFORMING ASSAYS, DISSOLUTION, HARDNESS TESTS, WATER CONTENT, CONTECNT/BLEND UNIFORMITY. ANALYTICAL TESTING OF EXCIPIENTS & APIs USING WET CHEMISTRY AS PER COMPENDIAL MONOGRAPHS.The Candidate:
• Bachelor of Science in Analytical Chemistry/Pharmaceutics with equivalent industry experience
• Master of Science in Analytical Chemistry/Pharmaceutics preferred
• 3 or more years of applicable industry experience in support of pharmaceutical product development
• Expertise in Instrumentation techniques: HPLC, GC, FTIR, UV, KF, and other wet chemistry testing.
• Experience with GMP and ICH regulations
• Requires excellent written and verbal communication
• Candidate must be comfortable in a fast-paced work environment
• Mathematical and reasoning ability
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to work effectively under pressure to meet deadlines.
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
Knowledge/Skills Requirements:
• Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
• Ability to learn and retain technical information
• Proactively address work issues at both an individual level and a team level
• Develop and execute complex procedures or methods with high quality
• Becoming familiar with drug development milestones and their context
• Recognizes and elevates changes in project scope or execution for review by project director
• Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization
• Propose deviations from established procedures and methods based upon sound judgment
• Excellent written and verbal communications skills with internal and external customers
• Supervisory skills are expected for Scientists with direct reports
• Can organize and manage teams chartered to address resolution of lab issues or special projects with general management guidance
• Lead by example according to Company’s values and culture
• Can assess training needs and formulate development plans for subordinates
• Recognize unmet customer needs
• Can effectively back-up supervisor to address limited technical or business issues with prior instructions
• Strategy is focused on personal and team time management and efficiency
• Well organized with ability to multitask
• Ability to work effectively under pressure to meet deadlines
• May publish or present externally
Physical Requirements:
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds
• Specific vision requirements including reading of written documents and the use of computer monitor screen frequently
• May require the use of a respirator
Scientist • Somerset, NJ
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