Associate Director, Sterile Operations

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 hypertension.Our 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 processes—from formulation through filling, inspection, Device assembly, labelling and Packaging operations—meet the highest standards of quality and efficiency. The primary focus of this role is maintaining rigorous compliance with global regulatory standards, specifically the revised EU GMP Annex 1 and FDA Guidance on Aseptic Processing . The successful candidate will lead the site's 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 guidance.Ensure 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: Bachelor’s degree in engineering, Microbiology, Biochemistry, or a related scientific field. Experience: A minimum of 8–10+ years in pharmaceutical manufacturing with at least 5 years in a leadership role specifically within aseptic fill‑finish operations. Regulatory Expertise: Deep, practical knowledge of the 2022 revised EU Annex 1 and current FDA CGMP regulations 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. #J-18808-Ljbffr