Position Summary:Provide advanced scientific and technical leadership in the development, optimization, scale-up, and lifecycle management of pharmaceutical manufacturing processes across the product lifecycle. Operate as a senior individual contributor within the process development department, applying a high degree of independence, technical judgment, and subject-matter expertise. Support clinical and commercial manufacturing by ensuring processes are scalable, robust, and compliant, while contributing to cross-functional technical decision-making and continuous improvement across MannKind's product portfolio.
Essential duties and key job responsibilities and essential functions: - Lead the design, development, and optimization of pharmaceutical manufacturing processes from late-stage development through commercialization.
- Apply sound scientific principles, experimental design, and data-driven methodologies to establish process understanding and improve process robustness and capability. Independently plan, execute, analyze, and document complex experimental studies in support of process development and process characterization.
- Serve as a subject matter expert for specific unit operations, process technologies, or platform processes, providing technical guidance across functions.
- Support process scale-up, technology transfer, and process validation activities by generating technical documentation and providing hands-on or consultative support.
- Collaborate cross-functionally with manufacturing, engineering, quality, analytical development, regulatory, and external partners to ensure successful process implementation.
- Manage equipment maintenance, including calibrations/qualifications.
- Support investigations related to process deviations, manufacturing issues, and continuous improvement initiatives.
- Author and review development reports, protocols, technical summaries, and regulatory documentation in compliance with cGMP and regulatory expectations.
- Contribute to process lifecycle management activities, including continuous improvement, change management, and technical risk assessments.
- Provide technical mentorship and informal coaching to junior scientists and associates to elevate team technical capability.
- Responsible for observing all Company, Health, Safety and Environmental guidelines.
- Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Minimum qualification to perform the job; specific skills; education; knowledge and job experience necessary to perform essential duties; physical requirements for job if any. - BS/BA with 6-8 years, MS with 4-6 years or PhD, or of relevant experience in Chemistry, Chemical engineering or a related field, with experience in pharmaceutical process development and/or manufacturing support.
- Experience in the development and scale-up of drug manufacturing processes.
- Experience preferred in the manufacture, packaging and kitting of clinical phase drug products.
- Experience with orally inhaled dosage forms is strongly preferred.
- Experience with the following unit operations preferred: spray drying, wet nano-milling, tangential flow filtration, micro fluidization.
- Experience managing second-party resources, including clinical packaging vendors and contract development and manufacturing organizations.
Pay Range: $97,600 - $146,400 per year
