Senior Manager Technical Operations
4 weeks ago
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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