<p>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.</p> <p>Job family summary:</p> <p>We are seeking a highly motivated and experienced scientist to join the Pharmaceutical Process Technology team. This role is to design, evaluate, and execute scientifically sound experimental plans to support the successful transition of drug product development from early to late clinical phases and to assist the regulatory filing and commercial manufacturing. This individual should have knowledge on phase- appropriate requirements for drug product development and will work closely with other CMC scientists and engineers to make critical decisions on process scale-up, optimization and validation.</p> <p>Essential duties and key job responsibilities and essential functions:</p> <ul> <li>Have a solid knowledge background to understand the critical properties of drug molecules, raw materials, and formulation requirements </li><li>Based on clinical needs, identify critical quality attributes of drug products and critical process parameters of manufacturing process </li><li>Develop, optimize, and scale-up the product manufacturing process to support ongoing studies </li><li>Design and execute scientifically sound experiments for process understanding and improvement </li><li>Build process knowledge base for process transfer and validation </li><li>Establish and maintain databases, document work and generate research & development reports </li><li>Contribute as individual contributor and work with teams to achieve developmental goals and ensure timely deliverables </li><li>Act as SME for process troubleshooting and provide recommendations </li><li>Perform independent literature research for problem solving in support of departmental and plant operations </li><li>Serve as an SME for manufacturing equipment, can make or suggest appropriate equipment adjustments for improved process engineering </li><li>Well versed with PAT tools for in-line process monitor and control </li><li>Participate in the design of scale-up equipment and new manufacturing suite </li><li>Support analytical development team activities and be the main player for building drug product specifications. </li></ul> <p>Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.</p> <p>Minimum qualification to perform the job; specific skills; education; knowledge and job experience necessary to perform essential duties; physical requirements for job if any.</p> <ul> <li>Master's degree in Chemistry, Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related Science field with 2 -6 years of relevant industry experience, or a PhD with 0- 4 years of experience in process or formulation development. </li><li>Basic knowledge of cGMP standards and regulatory guidelines for pharmaceutical development </li><li>Knowledge of process transfer, scale-up, and equipment engineering </li><li>Strong understanding of QbD, and experienced in DOE strategies for process understanding and optimization </li><li>Proficiency in data analysis and familiarity with technical tools/software (e.g., Excel, JMP, Minitab). </li><li>Detail-oriented with strong organizational & time management skills and the ability to contribute in a multidisciplinary team environment. </li><li>Strong written and verbal communication skills, with the ability to document findings and collaborate effectively. </li><li>Ability to write and execute protocols and assist in drafting detailed technical reports. </li></ul> <p>(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485, European requirements, etc.)</p>