Sr. Scientist/Engineer, Process Development

MannKind Corporation; Danbury (CT); On-site; USD 120,000 - 180,000; Full time

Job summary

MannKind Corporation in Danbury, CT seeks a senior scientist to lead pharmaceutical process development from late-stage through commercialization. You will optimize manufacturing processes, transfer tech, and ensure regulatory compliance within a cross-functional team.

The role emphasizes independence, data-driven decision making, and mentorship of junior scientists, with responsibility for process lifecycle management and continuous improvement.

Qualifications

• BS/BA with 6-8 years, MS with 4–6 years or PhD in Chemistry, Chemical Engineering or related field.
• Experience in pharmaceutical process development and/or manufacturing support.
• Experience in development and scale-up of drug manufacturing processes.
• Desirable: manufacture, packaging, and kitting of clinical phase drug products.
• Desirable: experience with orally inhaled dosage forms.
• Experience with unit operations such as spray drying, wet nano-milling, tangential flow filtration, micro fluidization.

Responsibilities

• Lead design, development, and optimization of pharmaceutical manufacturing processes from late-stage development through commercialization.
• Apply experimental design and data-driven methods to establish process understanding and improve robustness and capability.
• Serve as a subject matter expert for unit operations or platform processes, providing technical guidance across functions.
• Support process scale-up, technology transfer, and process validation with documentation and consultative support.
• Collaborate cross-functionally with manufacturing, engineering, quality, analytical development, regulatory, and external partners.
• Manage equipment maintenance, including calibrations/qualifications.
• Support investigations related to process deviations, manufacturing issues, and continuous improvement.
• Author and review development reports, protocols, technical summaries, and regulatory documentation in compliance with cGMP.
• Contribute to process lifecycle management and continuous improvement initiatives.
• Provide technical mentorship and informal coaching to junior scientists and associates.

Skills

Process development

Scale-up

Regulatory documentation

Cross-functional collaboration

Mentorship

Education

Bachelor’s/Master’s/PhD in Chemistry or Chemical Engineering

Job description

MannKind 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 MannKind, 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 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 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 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.

Minimum qualifications

• 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.