Associate Director, Supply Chain

Sun Pharmaceutical Industries Ltd•Cranbury, NJ

7d•$146,500 - $162,500

About The Position

The Associate Director will support the manufacture of Drug Product (fill finish, device assembly and secondary packaging) of biologics product. Responsible for activities range from tech transfer, technical process studies, process validation activities, data analysis to handing change controls, deviations and troubleshooting. Writing and reviewing of DP/Device Assembly/FG validation-related documents and key CMC sections of regulatory dossiers (different countries) are also required for this position. In addition, also represent and support supply chain team from commercial and clinical supplies of Biologics.

Requirements

Doctorate degree with 1-3 years of related experience - or- Master's degree and 3-5 years of related experience - or- Bachelor's degree and 5-7 years 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
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

Nice To Haves

Knowledge of analytical testing methods and impact on product quality specifications is advantageous.

Responsibilities

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 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.
Support the supply chain process for clinical and commercial programs to align with functional leaders and senior management on demand and supply plans.
Coordinates supply activities with Clinical Operations, Technical Operations, Regulatory, Quality Operations, and other departments as necessary to develop optimal supply strategies.
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