Engineer I, Process Development

Role Summary

We are seeking a highly motivated engineer to join the Process Development group supporting the small-molecule process development of respiratory drug products in the MannKind pipeline. The candidate is expected to support the development of our novel pulmonary formulations through contribution to the CMC project teams and must be able to meet development goals within ambitious timelines. The work environment is highly collaborative, requires excellent communication skills and the ability to be part of a cross-functional product development team.

Responsibilities

• Development and optimization of manufacturing processes from bench scale to commercial scale.
• Design, conduct, evaluate and interpret scientific studies to drive the development and understanding of our inhaled dosage forms.
• Support technology transfers to commercial manufacturing.
• Support equipment and process validation.
• Manufacture of development batches and GMP clinical lots.
• Assist in the management and troubleshooting of manufacturing operations, including product development studies and reviewing batch records.
• Author protocols, pharmaceutical development reports, SOPs, and other scientific/technical documents, which may support regulatory filings.
• Responsible for observing all Company, Health, Safety and Environmental guidelines.
• Responsible for observing all Company, Quality Assurance guidelines.
• Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.

Qualifications

• Exceptional scientific, technical, and problem-solving skills with the ability to design experiments and interpret data independently.
• Demonstrate an understanding of process development, analytical chemistry and drug product characterization.
• Knowledge of statistical analysis tools, in particular experimental design, and interpretation of complex data sets.
• Excellent technical laboratory skills.
• Excellent oral and written communication skills.
• Ability to think strategically and creatively.
• Experience with inhaled pharmaceutical products is a plus.
• Competency in the principles and practice of cGMPs for drug product manufacturing is a plus.
• Knowledge of materials science is a plus.
• Experience with process scale-up or working across process scales is a plus.
• Experience with manufacturing clinical and commercial drug products is a plus.
• Familiarity/experience with particle engineering and/or wet-stirred media milling and spray drying is a plus.

Education

• BS/BA in Chemical Engineering, Materials Science/Engineering, Chemistry, Pharmaceutical Sciences or a related field. 2+ years of relevant experience is preferred.
• Ability to work in a laboratory and manufacturing facility that handles active pharmaceutical ingredients.
• Must be authorized to work in the United States for any employer without the need for sponsorship.

Additional Requirements

• The role may require lifting 50 lbs and standing for long periods of time.