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Manufacturing Senior Associate

2 months ago

Thousand Oaks, California, United States BioPharma Consulting JAD Group Full time
Job Overview

BioPharma Consulting JAD Group is seeking a highly skilled MCS Manufacturing Senior Associate to join our team. This role is a critical component of our organization, contributing to the successful launch and management of new drugs in a cutting-edge manufacturing facility.

Key Responsibilities
  • Lead and manage New Product Introduction (NPI) projects and non-capital initiatives, ensuring timely delivery and adherence to quality and compliance standards.
  • Act as the change control owner, overseeing GMP-compliant records and ensuring timely closure in line with procedural guidelines.
  • Collaborate cross-functionally with Manufacturing, Quality Assurance, Process Development, Analytical Sciences, Regulatory Affairs, and other departments to drive process improvements and optimize operations.
  • Communicate effectively with staff, leadership, and external partners, presenting records and processes to internal and external audiences, including auditors and inspectors.
  • Identify and drive process improvements within the organization, building consensus for implementation and championing safety and compliance in all aspects of manufacturing and project management.
Requirements
  • Master's degree OR Bachelor's degree with 2 years of experience OR Associate degree with 6 years of experience OR High school diploma/GED with 8 years of experience.
  • Preferred qualifications include a Master's degree in life sciences or engineering, experience with PAS-X Werum software, and technical understanding of Drug Product manufacturing processes.