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Job Descriptions:
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Independently performs and supervises routine and non-routine tasks;
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Prepares detailed working plans and study protocols for assigned project;
Completes assigned project on time;
Prepares technical reports and presents results at staff meetings;
Performs instrument repairs, IQ, PQ, and OQ;
Provides technical guidance and trains junior staff regarding new instruments and technologies;
Conducts analytical, synthesis, and wet chemistry test as per the literatures and protocol;
Reviews and verifies the compendia methods and specification of commercial API and drug product.
Develops, and validates analytical methods, and writes SOP\'s.
Prepares and reviews data packages, and writes data package narratives;
Performs analytical research in supporting new drug development for the successful development of new drugs/products and generate data/reports for use by the client pharmaceutical companies as a part of their regulatory submission, such as INDs, NDAs, or ANDAs;
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Signs final reports and interact with clients to resolve technical problems;
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Conducts change control and deviation for established procedures and products;
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Conducts OOS investigations and drafts OOS reports;
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Complies with all relevant cGMP or GLP regulations and guidelines while carrying out of assigned studies, data analysis, interpretation and documentation;
Synthesis and characterize degradation product reference standards;
Interfaces with various function groups to ensure that project and timeline are met specifically for analytical supporting documents;
Provide leadership in project team;
Reports to team leader or Lab. director;
Requirements:
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Ph.D. in scientific discipline with a minimum of one year relevant experience in pharmaceutical or related industry;
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Or M.S. with a minimum of five years relevant experience in pharmaceutical or related industry;
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Or B.S. with a minimum of ten years relevant experience in pharmaceutical or related industry.
Familiar with modern analytical methodologies and instruments including, but not limited to HPLC, LC/MS, GC, GC/MS, TLC, PR-LC, UV-vis, IR, NIR, Titration, and In-vitro study
Familiar with basic synthesis procedure and new chemical characterization;
Familiar with SFDA and FDA guidance and ICH guideline;
Competent in technical English
