Ref : CMC-2021
Imcyse is a clinical-stage biotech company pioneering the development of a new class of active, specific immunotherapeutics known as Imotopes™. Imcyse’s Imotopes™ hold the promise to cure patients suffering from severe chronic autoimmune diseases for which there is no adequate therapeutic alternative. We are a highly dynamic world-class team dedicated to utilizing our unique Imotope™ technology platform to improve the lives of patients suffering from these debilitating diseases.
For its development Imcyse is looking for a:
CMC Coordinator (M/F/X)
The CMC coordinator is a member of the Technical Operations department in the Chemistry Manufacturing & Controls (CMC) Team. Under the supervision of the TecOps director, he/she is the primary contact point between Imcyse and CRO/C(D)MO’s in charge of GMP productions for all projects. In close cooperation with each Project Leader, he/she makes sure that each project will receive in time the pre-defined batch of non-GMP & GMP productions and the linked documentation. He/she is also able to anticipate problems and propose mitigation plan to the project team.
- Participate to Project Teams to identify the needs for CMC activities in every project
- Participate to the identification and the selection of the different CMOs
- Accountable for requesting quote and time slot of non-GMP/GMP peptide production; including fill & finish activities, stability studies follow-up
- Accountable for the completion on time and within budget of the Project Team decisions on CMC
- Perform risk management to minimize projects risks and inform the Project Leader for requested actions
- Report regularly project progresses and escalate successes/issues to the Project Team as needed
- Control and coordinate all QC activities required for the release of non-GMP and GMP productions (DS & DP), including coordination of stability studies
- Interact closely with the clinical Team and coordinate all logistic to provide in time batches required for Tox and clinical trials
- Manage interactions with CRO and CDMO’s
- Make sure that all documentation linked to peptide production is conform to standards in use and received in due time for a good project continuity
- Close interactions with the QA/RA person to provide all required documentation and information to complete IMPD and/or IND
- You have a Bachelor or Master in relevant scientific discipline
- You are quality oriented, a problem solver, flexible and team player
- You have excellent communication skills and are fluent in English (written and spoken)
- You have 3 to 5 years in Drug development or similar function
- Your skills and abilities:
- Define CMC scope and objectives based on Project needs
- CMC Activities, planning and priorities management of approved tasks
- Risk management and anticipation of problems
- Proactive Communication
- Interpersonal skills
- Critical thinking
- Analytical mindset
- You also master the below specialized knowledge:
- Project Management
- Drug production
- GMP practices
This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
We offer a permanent position in an innovating and dynamic company located near Liège and an attractive salary package in line with the position responsibilities and your experience.
Your application and related information will remain strictly confidential and will be used in the strict context of this recruitment, in line with GDPR.