Engineer I, Process Development

Role Summary

Engineer I, Process Development supporting the small-molecule process development of respiratory drug products. The role focuses on development of novel pulmonary formulations, contribution to CMC project teams, and meeting development goals within ambitious timelines in a collaborative cross-functional environment.

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 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

• Required: 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.
• Preferred: Experience with inhaled pharmaceutical products; competency in cGMPs for drug product manufacturing; knowledge of materials science; experience with process scale-up or across process scales; experience with manufacturing clinical and commercial drug products; familiarity with particle engineering, wet-stirred media milling, and spray drying.
• Familiarity/experience with particle engineering and/or wet-stirred media milling and spray drying is a plus.

Skills

• Exceptional scientific, technical, and problem-solving skills with the ability to design experiments and interpret data independently.
• Understanding of process development, analytical chemistry and drug product characterization.
• Knowledge of statistical analysis tools, especially 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.
• Experience with manufacturing clinical and commercial drug products 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.