Head of CMC

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 CMC to join its growing team. If you are interested in this unique opportunity, please submit your application (including a cover letter). 

About The Position
We are seeking a highly motivated individual to join us as Head of CMC. The Head of CMC will lead the development of the CMC strategy for our cell and gene therapy products and drive the development and execution of the CMC strategy with focus on all stages of product cycle. The individual will be accountable for developing and delivering the integrated CMC development plan while working closely with cross-functional teams internally (development, manufacturing, quality, regulatory) and with stakeholders to drive alignment and achievement of CMC development and manufacturing milestones in accordance with program timelines. In addition, the Head of CMC may also serve as project management interface between internal functions and external business partners. Reporting to the Chief Executive Officer, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.

Responsibilities
Lead and represent the cross-functional CMC team with focus on early/mid/late-stage programs through global commercial license application and approval
Define and implement an integrated CMC Product Development strategy for the programs and drive alignment with functional leaders and other key stakeholders
Work across functions to ensure development and manufacturing activities are delivered in accordance with timelines and executed on time according to plan
Align CMC team members on content and strategy and create synergy in activities. This includes manufacturing campaigns, process/analytical development, functional characterization, release testing, tech. transfer, comparability campaigns, stability studies, regulatory filings, and other CMC-related activities.
Track, compile, review, and ensure timely delivery of documents in support of regulatory filings and responses. Ensure the proper scientific rigor to deliver successful clinical outcomes.
Work with heads of department to ensure appropriate resourcing and budget development by strategic assessment of milestones and corresponding resource requirements, while providing periodic review of forecasted expenditures. Regularly communicates cross functionally to assess and confirm appropriate allocation and utilization of resources.
Provide guidance and mentorship to the functional leads/subject matter experts within the CMC team. Maximize alignment, cooperation, input, decision making, commitment and synergy of CMC team members to ensure their technical contributions meet/exceed program objectives. Builds and motivates teams to become high performing.
Actively involve and support the initiatives to support Product Lifecycle business operations, such as streamline development strategies across early to late stage projects, and establish knowledge management system.


Qualifications
BS/MS or PhD in a scientific field with ≥10 years of experience in biopharmaceutical development, preference in cell and/or gene therapy products.
Ability for critical thinking and innovation; highly motivated, willingness to acquire new skills.
Demonstrated successful cross-functional leadership track record and ability to work with tech ops teams to successfully drive results. Proficiency in strategic planning, cross-functional performance management, people dynamic management, and technical leadership.
In-depth technical understanding of early to late-stage clinical development of cell therapy products, including Process/Analytical Development, GMP Manufacturing CMC, and Regulatory.
In-depth experience with CMC Regulatory strategy to drive resolution of health authority questions or requests and the milestones and activities necessary to drive regulatory filing documentation.
Proven leadership experience and savvy influence skills with the desire and ability to work in a fast-paced, collaborative environment. Strong collaboration and team-building, communication, and organizational skills required.
Excellent written and verbal communication skills