Senior Manager

5 days ago


mumbai, India Michael Page Full time
Opportunity to work with one of the top 10 pharmaceutical companies in India. Opportunity for immense professional growth & exposure

About Our Client

Our client is among the top 10 pharmaceutical companies in India, with a global presence in over 100 countries.

Job Description

Lead and oversee the operational activities at DP/FG/Device Assembly CMO's; scheduling of batches, commercial manufacturing and testing of DP Responsible to achieve on-time in-full manufacturing of DP/FG/Device Assembly in compliance with approved dossiers in collaboration with Quality Assurance, Regulatory Affairs, and Analytical teams Serve as DP Subject Matter Expert (SME) on multidisciplinary CMC teams to ensure scientifically driven development and optimization of biological processes Review and approve master batch records, change controls, and deviations, CAPA to ensure GMP compliance and operational success Preparation and review of documents such as CPV reports, risk assessments, technical reports, validation documents, deviation reports and regulatory modules Responsible for Continuous Process Improvement and Process Optimization to reduce Cost of Goods Responsible for Tech Transfer and Process Validation into commercialization Plan and forecast budgets, analyzing variances for production and development testing and execute the day-to-day financial activities in accordance with procedures and contracts. The candidate will communicate across the organization to ensure key stakeholders are aware of project status, potential risks and their required action plans. Supporting post launch market surveillance of the product Other duties as assigned

The Successful Applicant

Education
, MS or degree in (bio) chemical engineering.
Professional Experience

Doctorate degree with 1-3 years (minimum) of related experience - or- Master's degree and 3-5 years (minimum) of related experience - or- Bachelor's degree and 5-7 years (minimum) of direct experience in Biologics Drug Product GMP manufacturing Experience in cGMP Biologics Drug Product is a must Knowledge of statistical tools like minitab/JMP for data analysis is required Knowledge of analytical testing methods and impact on product quality specifications is advantageous.


Skills & Abilities

Excellent interpersonal and communication, presentation skills Excellent organizational and project management skills, work well under pressure Ability to diagnose complex issues; develop and implement solutions by collaborating with other teams. Ability to influence internal and external stakeholders through scientific justifications Ability to thrive in a small group setting with limited administrative support

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