Sr. Scientist/Engineer, Process Development
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.
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