Senior Process Development Scientist – Pharma Manufacturing

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 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.