Join our team
Complix NV is continuously looking for dynamic and highly qualified people to join its talented team.
Principal CMC Manager
An exciting opportunity has arisen in Complix for a Principal CMC Manager to join their research team based in their research facilities in Zwijnaarde (Gent). Headquartered in Belgium, Complix is an established biotech company committed to the development of therapies for diseases with high unmet medical need including cancer and autoimmunity. Their proprietary technology is based on novel protein scaffolds known as Alphabodies. The structure of these Alphabodies confers the proteins with significant advantages over current protein-based therapeutic approaches and allows for the generation of novel biopharmaceuticals to address targets currently unamenable to more conventional approaches. The major focus of the company is the development of Alphabodies that can penetrate cells and thereby interfere with protein-protein interactions important in disease processes. Having secured a deal with a major pharmaceutical company, Complix is now looking to add to their team in Zwijnaarde.
Principal CMC Manager
Complix is seeking an experienced manager to head up the CMC team based in Gent (Technologiepark, Zwijnaarde). The role involves managing a team of in house PhD scientists and technicians and overseeing the outsourced production and testing of Complix preclinical and clinical products. The Principal CMC Project Manager will be a member of the overall program team, representing CMC, and will drive the development of comprehensive CMC project plans. This role will report directly to the CSO.
- Master degree (or Bachelor) in Biochemistry/ Biotechnology or equivalent
- 6-8 years industrial experience in CMC for biologicals preferably involving outsourcing
- In-depth knowledge of cGMP requirements for pharmaceutical or biotechnology environment and understanding of biologics manufacturing and/or bioprocess/product development; experience with antibodies is a plus
- Experience with CMC section of IND filings is a plus
- Demonstrated expert level people management skills. Ability to create effective relationships, motivate others and collaborate internally and externally at all organization levels.
- Hands-on experience and in depth technological know-how of the major biologics analytical methods
- Team player, enthusiastic, independent and self-motivated
- Expert level skills in communication, meeting management, and verbal, written, and presentation skills.
- High level of personal and professional integrity and trustworthiness with strong work ethic.
- Capability in the Microsoft suite of business software including MS Project and Excel
- English is required, other languages (e.g. Dutch and French) are a plus
- Management of the Complix CMC team including cross-functional matrix management to other Complix sites
- Development of large scale production processes (upstream and downstream) for Complix biologics
- Development and implementation of an appropriate analytical strategy for Complix products
- Oversight of tech transfer of processes and assays to contract research/manufacturing organizations
- Oversight of preliminary formulation and stability testing for Complix products
- Project management of all outsourced Complix CMC activities including:
- Process development
- Analytical development
- Cell line development
- Stability studies
- Clinical trials supply
- CMC budget planning and oversight
- Management the Complix CMC team to ensure the timely supply and QC of all discovery proteins
- Some US and European travel may be required
If you are interested in joining a dynamic and friendly team, please contact:
9052 Gent (Belgium)