Production Manager, Sterile Pharmaceutical Manufacturing
Overview
Lead and manage aseptic production operations at a top-tier pharma facility in Las Vegas. Oversee sterile injectable manufacturing ensuring compliance with cGMP and EU standards. Drive continuous improvement and cross-functional collaboration.
What You'll Do21
- 1Aseptic Production Operations
- 2Plan and execute sterile manufacturing activities including compounding filtration and aseptic filling
- 3Oversee ISO 5-8 cleanroom environments adhering to gowning and aseptic techniques
- 4Monitor production schedules and resolve operational issues
- 5Ensure cGMP (21 CFR Parts 210/211) and EU Annex 1 compliance
- 6Implement contamination control strategy covering personnel equipment and environment
- 7Partner with QA to investigate deviations and sterility failures
- 8Lead aseptic process validation and media fills
- 9Support IQ/OQ/PQ and sterilization validation processes
- 10Manage technology transfer from R&D to commercial manufacturing
- 11Oversee utilities HVAC HEPA filtration and WFI systems
- 12Lead equipment calibration and qualification of aseptic lines
- 13Develop and train aseptic teams in gowning and cleanroom practices
- 14Collaborate with QA QC Microbiology and Validation teams
- 15Coordinate with supply chain for sterile components and raw materials
- 16Prepare regulatory submissions and responses
- 17Track KPIs like batch success rate and EM trends
- 18Maintain MES/EBR data integrity and documentation
- 19Provide regular reports to leadership and drive improvements
- 20Ensure inspection readiness for FDA EMA and MHRA audits
- 21Drive contamination prevention and quality initiatives
Requirements12
- 110 years building sterile pharmaceutical manufacturing
- 215+ years in aseptic processing injectables or biologics
- 3Strong expertise in aseptic processing contamination control
- 4In-depth knowledge of EU Annex 1 FDA guidance
- 5Familiarity with isolators RABS and advanced aseptic technologies
- 6Experience with media fills sterilization processes
- 7Understanding of EM programs utilities WFI HVAC
- 8Proficiency in deviation management CAPA and regulatory inspections
- 9Leadership communication and decision-making skills
- 10BS/MS in pharmacy microbiology chemistry engineering
- 11Minimum Experience: 10 years
- 12Required Training: Quality Control Clinical Studies System Deployment Regulatory Affairs Auditing Validation
Salary Insight
$90 - $100k per year
Location
Required Skills
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