Junior project manager CMC

Junior Project Manager CMC

Location : Oss

We have an exciting opportunity available for a Junior 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 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, provide oversight for GMP manufacturing, identify new supply run needs, including all required financial, regulatory, and compliance documentation. The PM also manages the relation with the major manufac turers of the technology components.

What you will get:

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Compensation programs that recognize high performance.

• A variety of benefits dependent on role and location.

• The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits .

What you will 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

• Maintaining the compliance documentation in the Quality Management System

• 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 are looking for:

• PhD in Biotechnology , (Bio) chemistry, Bioengineering , Pharmacy, Molecular biology or a related discipline.

• Experience with Bioprocessing

• Project management skills

• Experience with GMP is c onsidered a plus

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now .