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Irfa******
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Canada
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Last Update: 13.06.2019 at 10:15
Job Type
Full Time
Start
Jun , 2019
Duration
6 Month
Place
Cambridge, Ontario, Canada
Country
Canada
Category
Description
Responsibilities include but are not limited to: Formulates new products, from development to commercialization, within defined company, industry, and regulatory parameters to support new drug submissions Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs) Creates Project Timelines in accordance with marketing priorities, sets milestones/critical path and ensures on time project completion Changes existing formulations to improve product cost and plays an active role in sourcing and evaluating raw materials for new or improved products Conducts patent searches to determine freedom to operate with a new formulation Establishes specifications for new and/or reformulated product and creates formula dockets and SOPs for transition to larger scale manufacturing and pilot tests Writes necessary documents and reports for manufacturing feasibility projects Prepares product registration documentation and product chemistry packages to meet regulatory requirements Develops new technologies related to pharmaceutical processing Participates in team driven activities to facilitate on- going production improvements or new product development projects Documents analytical test results as they occur in log books and in-process test data in Production dockets as required Other duties as assigned Skills Required: 2-5 years of drug formulation experience in a manufacturing environment, Experience with ANDA, ANADA, IND, and INAD submissions Bachelor of Science in Chemistry Basic HPLC and GC techniques, Strong understanding of cGMP guidelines and FDA regulations related to the pharmaceutical industry High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, and work in team environment, take initiative