Pokeacell ApS Copenhagen
PokeAcell is an early stage biotech company with a proprietary technology for personalized T-cell therapy preparing for phase I clinical study. We are an experienced team of science and business leaders founding PokeAcell with the vision to provide curative treatment to late stage cancer patients, where no treatment is available today. Our T cell therapy hold the promise of curative treatment in Melanoma, Merkel Cell carcinoma and high mutational burden tumors targeting Neo antigens
PokeAcell is embarking on a large CMC development project with multiple stakeholders including external CDMOs and CROs.
Therefore, we are looking for a proactive hands-on CMC Project Manager with 2 main responsibility areas.
- Identify and manage external sourcing and supply chain
- Coordinate and facilitate orderly progression of the project by interacting with all the stakeholders
Additionally, the CMC Project Manager will also be responsible for implementing a Quality Management System, QMS within PokeAcell.
As CMC Project Manager your responsibilities will be providing the necessary program planning, organizing, developing, and integrating projects across all stakeholders. You’re expected to closely monitor/control project progression to ensure the project is completed and on schedule within budget
In short some of your tasks will be:
- Identify and setup collaboration with external suppliers, CDMOs and CROs
- Manage external CDMOs and CROs on a daily basis
- Prepare and manage CMC budgets
- Implementation of QMS
- Serves as liaison with management, manages day-to-day communications and organizes project team meetings.
- Evaluate and assess project results and provide recommendations for future improvements.
- Cultivate effective communication, cooperation and trust.
One of the qualifications we are looking for in our new CMC Project Manager is strong and effective project management skills, with a proven track record working cross-functionally across a wide variety of technical- business- and operational areas. We expect you to have minimum of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing and minimum 3 years of project management experience. Additionally, a Master (MS) in life sciences; biotechnology/biochemistry or similar is preferred.
We are particularly interested the following competencies
- Proven experience in creating and carrying out successful plans and processes to solve complex problems
- Deep understanding of all CMC aspects involved in drug substance and drug product development
- Experience with CMC aspects within cell and gene therapy is a benefit
- Working experience with Quality Management Systems, QMS.
- Self-starter, self-motivated, organized and detailed-oriented personality
- Being able to work closely with team members across all CMC related business, management and steering team to ensure coordination of all efforts and real-time communication with all stakeholders.
- Excellent communications skills in English (verbal, written, and presentation skills)
We offer you to become part of a fun and professional team, shaping the future of PokeAcell and creating curative treatment to cancer patients. Give us a call to discuss more if your heart is beating faster than usual and you are ready for a new endeavor.
Reach out to Chief Technology Officer, Thomas Sandal at +45 22942918 or TS@pokeacell.com. We prefer applications before April 1.
Only applications from applicants already eligible to work in Denmark will be considered. Please apply via the button “Apply online” below.
Read more at www.pokeacell.com.