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