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Our mission is to develop a radically new approach for the treatment of severe, chronic autoimmune diseases.

CMC Coordinator

Permanent contract

Ref : IDT-CMC

About Imcyse

Imcyse is a clinical-stage biotech company pioneering the development of a new class of active, specific immunotherapeutics known as ImotopesTM. Imcyse’s innovative technology platform is based on the discovery of modified synthetic peptides that induce specific CD4 T-cells able to eliminate the pathogenic immune cells causing autoimmune diseases. Imcyse’s ImotopesTM hold the promise to cure patients suffering from severe chronic autoimmune diseases for which there is no adequate therapeutic alternative. Currently, a phase 2 clinical study is ongoing in type-1 diabetes and we are reaching completion of pre-clinical development in multiple sclerosis while projects in several other autoimmune diseases are at an earlier stage of development. We are a highly dynamic world-class team dedicated to utilizing our unique ImotopeTM 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)

The CMC coordinator is a member of the Technical Operations department in the Chemistry Manufacturing & Controls (CMC) Team. Under the supervision of the Head of IDT& CMC, 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.

Responsibilities

  • 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

Profile

  • 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 Pharmaceutical industry or CDMO’s with demonstrated experience in CMC activities
  • Your skills and abilities:
    o Define CMC scope and objectives based on Project needs
    o CMC Activities, planning and priorities management of approved tasks
    o Risk management and anticipation of problems
    o Proactive Communication
    o Interpersonal skills
    o Negotiation
    o Critical thinking
    o Analytical mindset
  • You also master the below specialized knowledge:
    o Project Management
    o DS/DP development, manufacturing and supply processes
    o GMP practices

Offer

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.

Interested ?

Please send your CV together with a cover letter to the following address: This email address is being protected from spambots. You need JavaScript enabled to view it.. Please, mention the reference 2022/IDTCMC.
Your application and related information will remain strictly confidential and will be used in the strict context of this recruitment, in line with GDPR.

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Address

Headquarters:

Avenue Pré-Aily 14
4031 Liège (Angleur)
BELGIUM

Phone : +32 (0)4 325 1100

Contact