Technical Manager (ms&t) Eso

Novartis

Hyderabad, India
On-site
Product lifecycle management
Process oversight and data trending
Ensuring product robustness and validation
As a product technology expert, you will be responsible for managing products throughout their lifecycle, overseeing processes through data trending and statistical analysis, and ensuring product robustness, proper validation status, and continuous process improvement

Job Summary

  • As a product technology expert, you will be responsible for managing products throughout their lifecycle, overseeing processes through data trending and statistical analysis, and ensuring product robustness, proper validation status, and continuous process improvement.
  • You will maintain oversight of processes for assigned products within contract manufacturing organizations, liaise with global product stewards, and cooperate with ESO functions to improve product process capability and maintain validation status.
  • Key responsibilities include controlling technical documentation, authoring/reviewing source documents for regulatory tasks, participating in deviation investigations, and ensuring product and process-related issues are remediated.

Matching Summary

As a product technology expert, you will be responsible for managing products throughout their lifecycle, overseeing processes through data trending and statistical analysis, and ensuring product robustness, proper validation status, and continuous process improvement.

Skills & Requirements

Must-have

  • Product lifecycle management
  • Process oversight and data trending
  • Ensuring product robustness and validation
  • Continuous process improvement
  • Liaising with global/X-CMO product steward
  • Technical documentation maintenance
  • Deviation investigation and CAPA remediation
  • Monitoring manufacturing performance

Nice-to-have

  • Science and risk-based approaches
  • Technical evaluation for CMO transfer
  • Statistical analysis of critical parameters
  • Working independently under pressure

Key Requirements

  • 10+ years of experience in biotechnology or pharmaceutical industry
  • Experience in large molecule and/or cell and gene therapy, and small molecules domains
  • Demonstrated experience in process and/or product technical roles
  • Good understanding of regulated environments and validation concepts
  • Experience with troubleshooting systems and processes
  • Proven ability to work effectively in a global, matrix team organization
  • Ability to work independently under time and pressure constraints

Work Rights

Not specified

Tailored Resume

Cover Letter