Head of Development

Procella Therapeutics AB is a start-up biopharmaceutical company on a mission to create stem cell-based therapy for heart disease and is seeking an outstanding Head of Development (Process/Analytical) to join its growing team. If you are interested in this unique opportunity, don't hesitate to submit your application (including a cover letter). 

About The Position
We are seeking a highly motivated individual to join us as Head of Development (Process/ Analytical). The Head of Development will be responsible for leading the process and assay development activities at Procella. This role will lead a team of Scientists to develop the process for a Phase 1 clinical study, perform process and assay characterization, and provide control strategies of process performance to ensure the process is efficient, on time, on budget and executed with high quality. Duties include managing and coaching staff from technical operations team (development), writing timelines and plans to move into Phase 1 studies, and developing annual budgets. Reporting to the Director of Development and CMC, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.


Job Responsibilities
Plans, directs and executes the development of processes and analytical assays for the manufacture of cell-therapy products in large scale in a GMP environment
Demonstrates a breadth of knowledge and skills to support the development, optimization, and management of protocols of high complexity to advance development of analytical methods and stem cell processes. Occasionally demonstrates subject matter expertise.
Plans, conducts and directs scientific work on extremely complex project necessitating the origination and application of new and unique approaches. Manage, monitor and control: safety, quality, costs and budgets.
Independently authors and approves technical documents, such as protocols, test methods, reports, certificates of analysis and operating procedures, with accuracy, thoroughness, and regulatory compliance
Leads the technical transfer of manufacturing processes and assays into GMP production
Represent the Process Development team both internally and externally
Identifies and independently drives department level improvements
Lead, motivate, and engage an energetic and innovative team of technical specialists. Continuously improve project execution.
Experience in Design of experiment statistical tools (e.g. JMP, DExpert, others)


Qualifications
PhD or Master’s Degree in biological engineering, chemical engineering, biological sciences or related field with 14+ years experience (8+ for PhD) in relevant industry experience
Cross-functional leadership capabilities with seasoned experience in people management, sub-functional oversight, and development
Strong communication skills, able to manage effectively multiple level communications up to management and down to project team members
Hands-on experience in mammalian cell culture, ideally differentiation and bioprocess manufacturing of pluripotent stem cells
Proven ability to structure, plan and execute in a fast-paced environment
Excellent organizational and problem solving skills, with demonstrated ability to extend these across a team implement efficient operational processes.