Senior Manager Technical Operations

4 weeks ago


Chicago, United States Avetix Group Full time

Avetix are partnered with an exciting Biotech based in Chicago. They are looking to add a Senior Manager of Technical Operations to their growing team


The right candidate must have: (please do not apply if you do not have the first)

Sterile Fill manufacturing experience

Familiar with API manufacturing


Essential Duties and Responsibilities:


  • Manage day to day technical operations matters within company. This includes investigations, deviation management, CAPAs, Veeva Maintenance, CMO Management etc.
  • Operations team member with responsibility to solve for technical or operational issues
  • Oversee the maintenance of technical operations for all suppliers. Manage change initiatives at suppliers in coordination with Regulatory and Quality Assurance.
  • Develop strategies for all products to meet supply needs and help resolve quality issues.
  • Oversee the management of interactions and set and maintain high standards and expectations of contractors and vendors who support company supply operations.
  • Provide input on Quality Assurance and Regulatory matters as needed.


Qualifications:

  • Knowledge of pharmaceutical sterile fill manufacturing. The candidate will preferably have experience working at a sterile fill manufacturing plant.
  • Familiarization with Active Pharmaceutical Ingredient (API) Manufacturing.
  • Familiarization with pharmaceutical tablet manufacturing.
  • Experience with managing investigations, change controls, CAPAs, deviations, etc.
  • Experience working with or managing Contract Manufacturing Organizations (CMOs).
  • Experience managing documentation within VEEVA or similar quality systems.

Experience with supporting regulatory filings and participating in regulatory inspections.


Base salary for this position - $135-150k per annum



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