Manager Product Development
Esquare Services (Pvt) Ltd, Pakistan

Job Purpose: Drive Research and Product Development Excellence to ensure a continuous high quality supply of New / BVO Drug Product(s) and Drug Substance(s) through the integration of Research / Manufacturing of Product Development with Laboratory Analytical Method Development to produce Quality Products with robust analytical methodologies and achieve industry First Time Quality (Right First Time) along with Manufacturing and Laboratory efficiency. The support also includes providing a library of knowledge for marketed products. Product Development: - Support the implementation of new initiatives from Business Development Group to develop new /BVO Products of local / Export opportunities - Establish a profound understanding of the science of products and process. - Research and Develop appropriate Qualitative and Quantitative Formula (QQF) for Product in Question - Prepare laboratory scale batch for technical evaluation and accelerated stability studies - Submit the samples to Business Development Group for their evaluation and acceptability. - Arrange raw and packaging materials for pilot scale batches - Identify and prepare feasibility for the manufacturing facility and equipment required for the manufacture of new /BOV Products - Prepare three pilot scale batches and place on stability studies as per Zone Requirements - Support procurement for new source development for New/BVO Products - Lead/direct appropriate manufacturing technology transfers and other supportive activities between development centres, sites, external suppliers, etc. - Support cGMP Product Inspections by Regulatory Authorities and Corporate. - Support the new/BOV Products registration with MoH and other Export Regulatory Submission Analytical Technology: - Support appropriate Specifications setting - Improving product, process and analytical methods robustness, and reaching excellence in operations - Research and develop Analytical Methods for Raw Materials used in new/BOV Products - Conduct Validation of new developed analytical methods for raw materials - Conduct Verification of available Compendia Analytical Methods for raw materials - Research and develop stability indicating Analytical Methods for new / BVO Products - Conduct Validation of newly developed Analytical Methods for new/BOV Products - Conduct Verification of available Compendia Analytical Methods for new/BVO Products - Arrange reference standards and impurities for the development of new stability indicating analytical method. - Support implementation of Process Analytical Technologies (PAT) to achieve real time release - Conduct Validation on first three commercial scale batches - Conduct Real time stability studies on first three commercial scale batches - Support in the Development of Artwork of Packaging Components - Lead/direct appropriate analytical method validations, transfers and other supportive activities between development centers, sites, external suppliers, etc. - Provide clear and timely analytical investigations of any product counterfeiting/customer complaint/contamination events supporting issue resolution with appropriate communication, escalation, and closure. - Support in Bio-equivalence / Bio-availability studies of the New/BVO Products

Skills & Competencies: Personal - Effective Communication Skills - Team Player & Motivator - Mature & Realistic approach towards job related assignments - Decision Maker - Diligent - Active - Foresightedness Technical: - Working with multicultural, cross-functional work teams - Understanding Global regulatory expectations - Project Management - Knowledge of Stability Programs and shelf life determination processes - Strong relationship with policy makers, government and industry bodies - Good written and oral communications skills in English and Urdu - Strong interpersonal and communication skills - Strong analytical skills with high commitment to excellence - Willing to work under pressure and thrive on working in new environment and new culture.