Associate Director, Sterile Operations
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Job Location:
Danbury, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
Overview
MannKind Corporationfocuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes nontuberculous mycobacterial (NTM) lung disease pulmonary fibrosis and pulmonary signature technologies dry-powder formulations and inhalation devices offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation depending on the target indication.
TheAssociate Director of Sterile operationsis a critical leadership role responsible for overseeing the daily operations of clinical and/or commercial sterile drug product manufacturing. This leader ensures that all aseptic processesfrom formulation through filling inspection Device assembly labelling and Packaging operationsmeet the highest standards of quality and efficiency.
The primary focus of this role is maintaining rigorous compliance with global regulatory standards specifically the revisedEU GMP Annex 1andFDA Guidance on Aseptic Processing. The successful candidate will lead the sites contamination control strategy and drive operational excellence in a high-stakes sterile environment.
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 the Subject Matter Expert (SME) for EU GMP Annex 1and FDA Aseptic Processing the facility remains in a state of constant audit readiness for global health authority inspections.
- Contamination Control Strategy (CCS):Lead the development implementation and periodic review of the site-wide CCS to mitigate microbial particulate and pyrogen risks.
- Sterility Assurance:Oversee various aseptic validation programs including Aseptic Process Simulations (APS/Media Fills) gowning qualifications and environmental monitoring (EM) strategies.
- Technical Ownership:Serve as the business owner for critical equipment such as isolators automated filling lines autoclaves Visual inspection systems etc.
- Quality Management:Lead investigations for sterility-related deviations environmental excursions and CAPAs utilizing root cause analysis to implement robust corrective actions.
- Cross-Functional Collaboration:Partner with Engineering Quality Assurance and Pharma Development to support technology transfers equipment qualification (IQ/OQ/PQ) and process validation runs.
- Team Development:Recruit mentor and lead a high-performing manufacturing team fostering a culture of safety data integrity and Right First Time performance.
Qualifications & Requirements
- Education:Bachelors degree in engineering Microbiology Biochemistry or a related scientific field.
- Experience:A minimum of810 yearsin pharmaceutical manufacturing with at least5 yearsin a leadership role specifically within aseptic fill-finish operations.
- Regulatory Expertise:Deep practical knowledge of the 2022 revisedEU Annex 1and currentFDA CGMPregulations for sterile drug products.
- Technical Skills:Proven experience with modern barrier technologies (Isolators/RABS) single-use systems (SUS) and aseptic processing techniques.
- Problem Solving:Strong background in Quality Risk Management (QRM) and the ability to navigate complex technical challenges during sterile production.
Required Experience:
Director
About Company
Drawing on the legacy of innovator and humanitarian Alfred E. Mann, our team of passionate scientists, researchers, and professionals develops cutting-edge therapeutic products and technologies that help people take control of their health and live—fully humann.
