Demo

Senior Bioprocess Engineer

The Steely Group
North Chicago, IL Full Time
POSTED ON 3/7/2025
AVAILABLE BEFORE 6/6/2025

My firm is seeking a direct hire Senior Biomanufacturing Operations Specialist to join our client's on-site, Chicago burbs team on a direct hire basis! This company was recently very highly rated as an excellent place work.

This role combines technical expertise, strategic leadership, and team management skills, ensuring the successful development and launch of injectable drug products.

Requirements :

  • Ideally, 7 years working on a biomanufacturing floor.
  • Able to work in a clean room environment environment is required.
  • Pharmaceutical or Medical Device industry experience is required.
  • Knowledge of FDA, cGMP, and ICH regulatory requirements is required.
  • Must be well organized, attentive to detail and have effective verbal and written communication skills.
  • Must be able to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment.

The compensation involves a Base Salary 10% annual bonus 1000 company shares.

Responsibilities

  • Support the Operations team in drug substance and / or drug product manufacturing.
  • Experience in new process implementation and continuous improvement
  • Help draft technical documentation for drug product and drug substance manufacturing.
  • Assist the Operations team with environmental monitoring, cleaning programs, and inventory management.
  • Experience leading Operations projects
  • Maintain manufacturing areas and process components to ensure a clean, safe and organized work environment.
  • Work collaboratively with and support the Development Lab and Quality teams.
  • Follow standard operation procedures (SOP) and work instructions to execute tasks.
  • This role combines technical expertise, strategic leadership, and team management skills, ensuring the successful development and launch of injectable drug products.

    Requirements :

  • 7-10 years working in manufacturing or laboratory operations is required.
  • Able to work in a clean room environment environment is required.
  • Pharmaceutical or Medical Device industry experience is required.
  • Knowledge of FDA, cGMP, and ICH regulatory requirements is required.
  • Must be well organized, attentive to detail and have effective verbal and written communication skills.
  • Must be able to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment.
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