Project Manager CMC

Project Manager CMC

Lonza

Oss, Netherlands

We have an exciting opportunity available for a Project Manager within the Chemistry Manufacturing and Control (CMC) group at Synaffix. The CMC group at Synaffix is responsible for the the CMC activities that are required by our current and future partners in the development of their drug products, through clinical proof-of-concept and first-in-human testing. The project manager manages the technical business relation, serves as the single point of contact for several licensees of the Synaffix technology, and is responsible to leverage this relation to gain insight in the clinical development needs and translate this to a near to mid-term supply need per licensee. The project manager also manages one or more of the Synaffix technology components. In this capacity the PM is responsible to set the development strategy, identify and order new supply run needs, including all required financial, regulatory, and compliance documentation. The PM also manages the relation with the major vendors of the stock components.

What you’ll do:

• Developing and managing scalable production processes and testing and release of our platform components at various CDMOs
• Building and maintaining long term relationships with our contract manufacturing and development organizations (CDMOs)
• Maintaining the regulatory support files for the platform components
• Building and maintaining relations with the technical representatives of licensees of our technology
• Collaborating with legal counsels to draft and maintain contracts with CDMOs and licensees
• Supporting and collaborating with other CMC team members on external and internal development and other projects
• Perform other duties as assigned.

What we’re looking for:

• PhD in the field of Chemistry, Organic Chemistry, Biotechnology, Pharmacy, Molecular Biology, Biosciences
• 1-4 years experience in similar industry position
• Strong technical knowledge of synthetic organic chemistry processes
• Proven project management skills with experience in organizing, prioritizing, planning, and executing multiple projects and programs
• Experience with GMP is considered a plus