Sr. Scientist/Engineer, Process Development
Listed on 2026-07-20
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Pharmaceutical
Validation Engineer, Quality Engineering -
Engineering
Process Engineer, Validation Engineer, Quality Engineering
Mann Kind Corporation is a biopharmaceutical company focused on transforming chronic disease care through patient-centric solutions, developing and commercializing inhaled therapeutics and drug-device technologies for unmet needs across endocrine, cardiorenal, and orphan lung diseases.
At Mann Kind, our employees are a core asset, and we foster a collaborative culture where each team member contributes to improving health outcomes and changing lives.
Position SummaryProvide 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 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 Mann Kind’s product portfolio.
Essentialduties and 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 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.
- Observe 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.
- BS/BA with 6-8 years, MS with 4–6 years or PhD, or 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.
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