Sr. Scientist/Engineer, Process Development
About The Position
MannKind Corporation is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient‑centric solutions, developing and commercializing innovative inhaled therapeutics and drug‑device technologies aimed at addressing serious unmet needs across endocrine, cardiorenal, and orphan lung diseases. The company applies deep expertise in formulation science and inhalation‑device engineering to reduce the treatment burden for conditions such as diabetes, congestive heart failure, pulmonary fibrosis, and pulmonary hypertension. MannKind’s core technologies, including ultrafine dry‑powder formulations and advanced inhalation platforms, enable rapid, convenient delivery of medicines directly to the deep lung. This approach supports both local pulmonary targeting and systemic delivery for various medical indications. Through alternative drug formulations and delivery mechanisms, MannKind aims to bring forward differentiated, patient‑centric therapies that expand treatment options to improve outcomes across chronic and rare diseases. At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives. 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.
Requirements
- 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 managing second-party resources, including clinical packaging vendors and contract development and manufacturing organizations.
Nice To Haves
- 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.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
