Product Development & Commercialisation Group leader

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.

Summary of Position
pMDI Product Development & Commercialisation Workgroup leader required to support multiple metered dose inhaler NPI projects. This is an exciting role to lead 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 and future technologies by applying their creative technical skills and scientific experience to solve complex technical challenges.

Job Responsibilities

• Leadership of R&D Product Development & Commercialisation Workgroup responsible for driving the strategy of the group and having accountability for the work of the group.
• Development of strategy for Manufacturing Process Development, Development Pharmaceutics, Stability, Specification and Data Analysis activities for pressurised metered dose inhaler NPI programmes
• Delivery of protocols, data analysis and interpretation, reports and documentation required for submission to Regulatory Authorities
• Support to manufacturing activities at Laboratory, Pilot Clinical and Commercial scale
• Data analysis and interpretation to support formulation, product & manufacturing process development activities enabling CQA/CPP and specification development
• Provision of accurate resource estimates for project tasks/activities. Ensure project plans are updated and tracked and that actual vs. planned hours are controlled.

Minimum Requirements

• 5+ years of late stage inhalation product development experience. (preferably pMDI)
• Bachelors degree or higher in Science based or Mathematics/Statistics based subjects from an accredited university.
• Demonstrated experience in supervising, leading and coaching technical staff
• Demonstrated ability to develop and define finished product and manufacturing process development strategy for inhalation products, using principles QbD and Design Controls
• Demonstrated data analysis and interpretation skills. Statistics knowledge, Design of Experiment (DoE) and data modelling
• Demonstrated data analysis and interpretation skills. Statistics knowledge, Design of Experiment (DoE) and data modelling
• Demonstrated strong oral and written communication skills.
• Able to multitask and remain flexible to changing project priorities.
• Work well both as an individual and in a team environment.

Preferred Experience

• Familiar with CMC Documentation (IND/NDA, IMPD/MAA)
• Familiar with statistical evaluation of data, in-silico modelling and IVIVR
• Familiar with pressure filling of metered dose inhaler products
• Familiar with working in a cGMP manufacturing environment