Senior Process Chemist, API

Responsibilities

• -Responsible for API manufacturing process technical support and improvement initiatives for ongoing operations.
• -Develops API analytical techniques including HPLC, GC, FTIR, titration and other analyticalmethods for process characterization and process mapping.
• -Experience in establishing a robust GMP documentation system for data recording including ELN and Empower, ensuring data integrity and compliance with regulatory standards.
• -Acquire knowledge on setting up empower and electronic lab note book
• Designs and executes process improvements and lab studies/experiments
• Serves as at echnical SME; Provides technical expertise to production and S&T
• Addresses and solves technical problems independently.
• -Performs independent, advanced and complex data analysis.
• -Generates new ideas and demonstrates a high level of scientific initiative.
• -Responsible for continuous process improvement activities.
• -Identifies equipment or techniques that improve manufacturing processes and operations.
• -Authors technical reports and monitors consistency and quality of technical reports.

Requirements

• -Bachelor's, Master's in scientific or engineering discipline with 3 to 5+ years of Active Pharmaceutical Ingredient (API) Manufacturing experience, depending on degree held.
• -Candidate with knowledge of setting up GMP lab is preferred.
• -Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required
• -Demonstrated strong process development skills,including the ability to deliver innovative process chemistry at scale.
• Strong record of scientific accomplishment
• -Proficiency with Empower software
• -Demonstrated record of independent thought and creativity
• -Bases technical decisions, within own discipline, on sound engineering or scientific judgment.
• -Evaluates and integrates appropriate state-of-the-art technology to improve processes or solve problems.
• -Gathers information from multiple sources to assist in problem solving.
• -Understands and aligns project goals with business objectives.
• Contract Duration: 6 months

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