Project Manager CMC

Netherlands, Oss

Posted Job Advert

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

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 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 (18-months) 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.

Key accountabilities:

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;
Performing practical logistical support to bring our platform components to the 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.

Skills and Education:

Project management skills with experience in organizing, prioritizing, planning, and executing multiple projects and programs;
Experience with GMP is considered a plus;
Experience with international global supply chain management is considered a plus;
M.Sc. or PhD in Organic Chemistry, Biochemistry, Life Sciences, Biomedical Sciences or related;
Dutch working permit required, no company sponsorship;
Experience 0-4 years;
Very strong communication, assertive, pro-active and commercial skills. Good social skills are more appreciated than killer mentality;
Teamplayer (team contains six professionals in total);
Language skills in English.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.