Scientist II, Product & Process Development

ROLE SUMMARY

The person hired for the position of pMDI Product Development Scientist will support the development and testing of pMDI pharmaceutical products from early development through final submission of regulatory dossiers.

This is an exciting role within an expanding team of process and product development specialists and offers the successful candidate an opportunity to make a significant contribution to the development of new inhalation products by applying their creative technical skills and scientific experience to solve complex technical challenges.

ROLE RESPONSIBILITIES

• Ensure world-class safety within the laboratory and Kindeva Headquarters Facility.
• Plan, organize, assist/lead pressurized metered dose inhaler product development activities using a range of laboratory equipment and preparation techniques.
• Delivery of protocols, data interpretation and reports from early development to submission to Regulatory Authorities for pressurized metered dose inhaler development programs.
• Management and maintenance of laboratory equipment and associated documentation. 
• Provide global support to activities at Laboratory, GMP, Pilot, and Commercial scale. 
• Other duties as assigned.

BASIC QUALIFICATIONS

• Bachelor’s degree or higher in a science discipline from an accredited university.
• 2 + years of working experience within a GMP environment.
• Demonstrated practical laboratory skills gained in a pharmaceutical development environment.
• Demonstrated data analysis and interpretation skills.
• Demonstrated strong oral and written communication skills.
• Strong mechanical aptitude.
• Able to multitask and remain flexible to changing project priorities.
• Work well in both team and individual environments.
• Strong problem solving skills and ability to think outside the box. 

PREFERRED QUALIFICATIONS

• Bachelor’s degree or higher in Chemistry or Engineering from an accredited university.
• Minimum of 2 years inhalation product development experience, preferably pMDI.
• Experience with the use and maintenance of pMDI manufacturing equipment.
• Familiar with QbD, design controls, and CMC documentation.