Associate Director, Sterile Opertions

MannKind Corporation focuses 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.

The Associate Director of Sterile operations is 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.