This is a remote position with occasional travel estimated at 25%.
Kaléo has secured multiple contracts with the U.S. government for production of new medical countermeasures, with commercialization opportunities to follow. The person in this role will have a critical role in the successful execution of these programs, and will lead the analytical, formulation, and manufacturing drug development activities necessary to achieve and maintain marketing approval for these products. This is a phenomenal opportunity for a strong leader and experienced subject matter expert in drug product process development to be part of an exciting, fast-paced program making a life-saving product.
As Director, Drug Development, you will:
- Direct and participate in formulation studies to assess new product feasibility.
- Develop formulations and manufacturing processes for pilot, registration, and commercial batches.
- Design and characterize new formulations and ensure that they can be transferred into existing drug products manufacturing site for scale-up.
- Direct compounding of lab batches and design stability studies to determine optimal drug product shelf life.
- Collaborate with Quality, Product Development, Manufacturing Science & Technology (MS&T) and Regulatory Affairs departments to coordinate pilot, registration and commercial batches.
- Direct analytical method development, method transfer, and stability studies for raw materials and finished drug products.
- Collaborate with MS&T) on analytical method validation.
- Establish specifications, compounding records, and technical protocols/reports including CMC drug substance and drug product sections to support Regulatory Affairs in FDA submissions.
- Establish drug development plans and budgets, including selection and management of CROs and CMOs associated with drug formulation and process activities.
- Review and approve drug development standard operating procedures, batch records, protocols, study reports, reports, non-conformances, deviations, investigations, confidentiality agreements, research and development agreements and purchase orders.
- Periodically review ongoing drug product quality testing results and provide drug product subject matter expertise to help identify trends for investigation, and participation in those investigations.
A successful Directory, Drug Development will have:
- A proven understanding of the biopharmaceutical industry.
- The ability to manage complex projects from initial stages to completion and resolve complex issues.
- Must possess excellent supervisory, interpersonal, leadership, and project management skills.
- The ability to communicate impactfully with all levels of internal and external personnel, as well as regulatory authorities.
- Experience setting and maintaining project budgets and timelines.
- An innovative outlook with an emphasis on collaboration and intellectual curiosity.
- A commitment to upholding an inclusive environment across the team and organization.
To be considered for the position, you must have:
- Advanced (MS or PhD) degree in Life Science and a minimum of 6 years of experience OR a BS degree in a Life Science and a minimum of 12 years of experience.
- Biopharmaceutical experience in drug product and regulatory development including formulation development, analytical development, and parenteral manufacturing preferred.
Application required for consideration. Please contact talentacquisition@kaleo.com with any additional questions.
