At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have a globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies.

We are seeking a highly motivated Senior Project Manager. The Senior Project Manager, reporting to the Head of Procella, will lead and manage complex projects in the field of targeted delivery of cell therapies a new modalities, tissue-engineered products, and other advanced medicinal products. This role requires a deep understanding of the regulatory landscape, manufacturing processes, and clinical development pathways specific to ATMPs. 

The successful candidate will oversee cross-functional teams to ensure timely and on-budget delivery of projects while maintaining the highest standards of quality and compliance. The role will also need to coordinate work within a cross-functional team of other heads of department, scientists and research technicians, collaborate across functional groups internally and externally. This position is ideal for an individual who is driven and passionate about cell therapy in a fast-paced one-team collaborative environment.

Key Responsibilities

Project Leadership:

Lead the planning, execution, and closing of ATMP projects, ensuring alignment with company goals and regulatory requirements.

Stakeholder Management:

Develop and manage detailed project plans, timelines, and budgets.

Coordinate and oversee the work of cross-functional project teams, including R&D, regulatory, clinical, and manufacturing departments.

Act as the primary point of contact for project stakeholders, including internal teams, external partners, and regulatory bodies.

Facilitate effective communication and collaboration among stakeholders to ensure project objectives are met.

Prepare and deliver regular project updates, presentations, and reports to senior management and other stakeholders.

Regulatory Compliance:

Ensure all project activities comply with relevant regulatory requirements and guidelines for ATMPs (e.g., FDA, EMA, GMP).

Coordinate regulatory submissions and interactions with regulatory authorities.

Stay updated on changes in the regulatory landscape and assess their impact on ongoing and future projects.

Risk Management:

Identify potential project risks and develop mitigation strategies.

Monitor project progress and adjust plans as necessary to address emerging risks and issues.

Conduct regular risk assessments and update risk management plans accordingly.

Quality Assurance:

Ensure all project deliverables meet the highest standards of quality and compliance.

Collaborate with Quality Assurance teams to conduct audits and reviews of project activities and outputs.

Implement continuous improvement initiatives to enhance project performance and outcomes.

Budget and Resource Management:

Develop and manage project budgets, ensuring efficient use of resources.

Monitor project expenditures and take corrective actions to address budget variances.

Coordinate resource allocation and utilization across project teams.

Team Leadership and Development:

Mentor and guide project team members, fostering a culture of collaboration and excellence.

Conduct performance reviews and provide feedback to team members.

Identify training and development needs and facilitate professional growth opportunities for team members

PREFERRED QUALIFICATIONS

• Ph.D. in cell and/or molecular biology, biochemistry, biotechnology or another relevant field with at least 10+ years of of relevant experience in Project Management in ATMP
• MBA desirable

Proven experience in Senior Project Manager - Advanced Therapy Medicinal Products (ATMP)

Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.

SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 69 employees from more than 20 nationalities.