CMC Project Manager at ISA Pharmaceuticals
Founded in 2004, ISA Pharmaceuticals is a privately held company based in Leiden, the Netherlands. With a dedicated team of 25 professionals, ISA focuses on the development of immunotherapies for the treatment of cancer and persistent viral infections. ISA’s immunotherapy platform is based on its proprietary SLP® (Synthetic Long Peptide) and AMPLIVANT® technologies. Various clinical trials up to completion of Phase II have demonstrated the safety, tolerability and clinical efficacy of SLP® immunotherapies. Because of our ongoing expansion we have the job opening for a CMC Project Manager.
Your challenges are to drive partner CMC (Chemistry, Manufacturing and Controls) manufacturing and validation projects based on ISA’s proprietary SLP® platform. You will help revolutionize clinical development by exploring new technology innovations and regulatory pathways for our products.
In addition to project management tasks, you will coordinate, write, and review CMC documentation such as project plans, reports, and regulatory filings. You will closely collaborate with other departments as well as with external partners.
You have a MSc or PhD degree in Life Sciences or Chemistry with over 5 years relevant experience. You will be the key project interface for and between the ISA (project) teams and our GMP manufacturers of drug substance and drug product. You have experience with project management and regulatory submissions and knowledge of quality systems and GMP manufacturing and preferably process validation. You are flexible, possess good communication skills, and can act as a team player as well as team leader. You have a can-do mentality and good problem solving skills.
We offer you a challenging position in a rapidly developing organization. You will be part of a team of young top professionals, work with state of the art equipment and technologies in an inspiring environment with opportunities for personal and professional growth.
For further information on this job opening and related career opportunities, please contact Brigitte Burm at email@example.com or +31 71 3322310. Acquisition based on this advertisement is not appreciated.