Associate Director, Sterile Opertions
MannKind Corporation
5 hours ago
On-site
Danbury, CT
$148,000 - $222,000 USD yearly
Operations
Key Responsibilities
- Operational Leadership: Direct daily fill-finish operations including drug product formulation, aseptic filling, device assembly, visual inspection, and secondary packaging.
- Regulatory Compliance: Serve as SME for EU GMP Annex 1 and FDA aseptic processing guidance; maintain constant audit readiness.
- Contamination Control Strategy (CCS): Develop, implement, and periodically review the site-wide CCS to mitigate microbial, particulate, and pyrogen risks.
- Sterility Assurance: Oversee aseptic validation programs including APS/media fills, gowning qualifications, and environmental monitoring (EM).
- Technical Ownership: Business owner for critical equipment such as isolators, automated filling lines, autoclaves, and visual inspection systems.
- Quality Management: Lead investigations for sterility-related deviations, environmental excursions, and CAPAs using root cause analysis.
- Cross-Functional Collaboration: Partner with Engineering, Quality Assurance, and Pharma Development for technology transfers, IQ/OQ/PQ, and process validation runs.
- Team Development: Recruit, mentor, and lead a manufacturing team; foster safety, data integrity, and “Right First Time.”
Qualifications & Requirements
- Education: Bachelor’s degree in engineering, Microbiology, Biochemistry, or a related scientific field.
- Experience: 8–10+ years in pharmaceutical manufacturing; at least 5 years in a leadership role in aseptic fill-finish operations.
- Regulatory Expertise: Practical knowledge of the 2022 revised EU Annex 1 and current FDA CGMP regulations for sterile drug products.
- Technical Skills: Experience with barrier technologies (Isolators/RABS), single-use systems (SUS), and aseptic processing.
- Problem Solving: Strong background in Quality Risk Management (QRM).
Pay Range
- $148,000 - $222,000 per year
- Operational Leadership: Direct daily fill-finish operations including drug product formulation, aseptic filling, device assembly, visual inspection, and secondary packaging.
- Regulatory Compliance: Serve as SME for EU GMP Annex 1 and FDA aseptic processing guidance; maintain constant audit readiness.
- Contamination Control Strategy (CCS): Develop, implement, and periodically review the site-wide CCS to mitigate microbial, particulate, and pyrogen risks.
- Sterility Assurance: Oversee aseptic validation programs including APS/media fills, gowning qualifications, and environmental monitoring (EM).
- Technical Ownership: Business owner for critical equipment such as isolators, automated filling lines, autoclaves, and visual inspection systems.
- Quality Management: Lead investigations for sterility-related deviations, environmental excursions, and CAPAs using root cause analysis.
- Cross-Functional Collaboration: Partner with Engineering, Quality Assurance, and Pharma Development for technology transfers, IQ/OQ/PQ, and process validation runs.
- Team Development: Recruit, mentor, and lead a manufacturing team; foster safety, data integrity, and “Right First Time.”
Qualifications & Requirements
- Education: Bachelor’s degree in engineering, Microbiology, Biochemistry, or a related scientific field.
- Experience: 8–10+ years in pharmaceutical manufacturing; at least 5 years in a leadership role in aseptic fill-finish operations.
- Regulatory Expertise: Practical knowledge of the 2022 revised EU Annex 1 and current FDA CGMP regulations for sterile drug products.
- Technical Skills: Experience with barrier technologies (Isolators/RABS), single-use systems (SUS), and aseptic processing.
- Problem Solving: Strong background in Quality Risk Management (QRM).
Pay Range
- $148,000 - $222,000 per year