Pharmaceutical Development Manager

hace 21 horas


San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

Key Responsibilities

  • Lead and manage complex projects related to the development, validation, and commercialization of aseptic pharmaceutical or medical device products.
  • Coordinate and oversee all stages of project execution from design, development, and validation through to FDA submission.
  • Develop project timelines, resource allocation plans, and budgets, ensuring timely and on-budget delivery.
  • Prepare and review documentation for FDA submissions and other regulatory filings.

Requirements

  • Bachelor's degree in Engineering, Life Sciences, or a related field (Master's degree preferred).
  • 8+ years of experience in project management in a regulated pharmaceutical, biotechnology, or medical device industry, with a focus on aseptic areas and FDA submissions.
  • Proven track record of leading projects through FDA submissions.
  • Strong knowledge of FDA regulations (CFR Part 210/211, 21 CFR Part 820), aseptic processing, validation protocols, and good manufacturing practices (GMP).
  • Experience with process validation, cleaning validation, and equipment qualification in aseptic manufacturing.


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