20/07/2021 12:44:36 4000 Luik

CMC Manager Biologicals


  • Exevir Bio bv
  • 4000 Luik
  • Pharmaceutical and Healthcare
  • Onbepaalde duur
  • Vast contract
  • Voltijds
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ExeVir Bio is harnessing its VHH technology platform to generate robust antiviral therapies providing broad protection against viral infections, including coronaviruses.

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Job description

The CMC Manager is responsible for Technical Project Management of Exevir’s projects. The CMC Manager is responsible for leading and managing all technical activities for assigned projects including Drug Substance and Drug Product manufacturing process and analytical development, considering all aspects for ensuring pre- and clinical supplies on time and all related documentation for future CMC submission to regulatory agencies.

The CMC Manager will be responsible for:

  • Manage the CMC operational activities relating to manufacturing of Exevir products (nonclinical and clinical grade) under ICH/GLP/GMP requirements
  • Contribute to technical development strategy and assure integration into the overall project strategy to meet program timelines and budget for all manufacturing and CMC activities
  • Follow-up and coordinate the activities conducted by Contract Research Organizations (CROs)/Contract Development and Manufacturing Organizations (CDMOs) related to assigned CMC programs. This comprises the successful delivery of product from pilot through clinical scale batches
  • Attend and present progress at PTMs (Project Team Meetings), and ensure clear and synthetic regular presentations of the status, results and issues of the assigned CMC programs
  • Anticipate problems/difficulties (technical business and regulatory) and recommend mitigation for emerging risks
  • Assist in preparing the package of CMC documents for Registration (IMPD, INDs and Investigator Brochure)

Job Environment/ Interactions:

  1. Report to the Head of External Manufacturing
  2. Project Team Member responsible of CMC activities
  3. Work closely with CMO and CRO’s staff to ensure excellent relationships between Exevir and its suppliers
  4. Work closely with internal legal, quality, pre-clinical and clinical teams
  5. Host CMC technical meetings

Profile

Minimum Qualifications/Experience:

  • Engineering Degree, Master or Ph.D in Sciences
  • Minimum of 5 years of experience in bioprocess, manufacturing and analytical field with technical and management responsibilities in the industry
  • Very good knowledge in GMP, biomanufacturing sciences, QA/QC and regulations.
  • Demonstrated ability to lead development and manufacturing activities conducted by CROs/CDMOs
  • Analytical thinker with problem-solving mindset
  • Good written and oral communication skills
  • Fluency in English as a business language

Personal Attributes:

  • Excellent planning, organization and time management skills
  • Desire to work in a fast paced, team-oriented dynamic environment
  • Highly proactive, self-motivated, professional and dedicated
  • Autonomous, rigorous, and careful to details
  • Resistant to stress

Questions?

Contact Elien De Durpel on +32 9 242 54 13.

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