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Besins Healthcare PharmTech
CMC Team LeaderBesins Healthcare PharmTech • Liège, Walloon Region, Belgium
CMC Team Leader

CMC Team Leader

Besins Healthcare PharmTech • Liège, Walloon Region, Belgium
6 dagen geleden
Functieomschrijving

To lead the day-to-day operational execution of CMC manufacturing/development trials activities (R&D/GMP), Besins Healthcare Pharmtech is hiring a CMC Team Leader.

The CMC operational manufacturing activities encompass feasibility, development, optimization, transfer, qualification/validation and monitoring, from feasibility up to commercial lifecycle stages.


Your responsabilities


The CMC Team Leader will:

  • Ensure all activities (within scope of responsibility) are executed following applicable policies, procedures, EHS, quality, regulatory and legal standards.
  • Supervise a team of CMC operational associates (including mentoring, training, personal development).
  • Participate in global planning definition.
  • Manage operational CMC departmental day-to-day planning to achieve departmental and site objectives.
  • Ensure a smooth/efficient workflows and execution coordination/ collaboration with the other operational departments/experts/third parties (e.g. service providers…) of the CMC operational activities.
  • Proactively identify, assess, communicate risks and drive continuous improvement of business processes, CMC operational documentation and training material.
  • Edit documents related to CMC operational activities (SOP, instructions, work documents…).
  • Participate in quality event investigations, CAPAs and change controls.
  • Ensure all relevant information and operational activities relating to CMC manufacturing/development trials are tracked, captured, completed, and as needed, proactively shared with CMC project teams.
  • As System Owner, oversee CMC areas related activities are appropriate and executed on schedule and in a cost-effective manner (e.g. cleaning, environmental monitoring, equipment/area periodic maintenance, consumables management…).
  • Participate in qualification/validation activities for area of responsibility, including development, writing/review, and executing, protocols and completion of final reports.
  • Assist N+1 in the budget definition/follow up for the CMC operational activities.
  • Contribute to internal projects programs as per defined by the strategic committee.



Your profile


  • Bachelor’s Degree in Scientific discipline
  • 5 or more years’ practical experience in a pharma R&D/cGMP regulated environment
  • Minimum of 2 years of supervisory experience
  • Strong interpersonal communication skills and ability to thrive in a dynamic team environment and strengthen an efficient collaboration with other internal stakeholders.
  • Organizational and leadership skills with ability to effectively delegate work
  • Ability to prioritize and agility/flexibility to adapt to changes, inherent to R&D development activities
  • Ability to take initiative and work proactively with creative problem-solving skills
  • Experience in Quality Risk Management
  • Root cause analysis: experience with investigation and troubleshooting methodologies
  • Strong technical writing skills
  • Lean or similar continuous improvement methodologies is a plus
  • Position may require employees to work shifts, holidays, and weekends
  • Technical expertise with pharmaceutical/medical device grade polymer, hot melt extrusion/injection and with terminal sterilization techniques is an asset
  • Fluent in French and English (written/spoken)
  • Natural leadership and strong capabilities to make people work together with efficient collaborations
  • Autonomous
  • Pragmatic
  • Factual/data-based decision making
  • Open minded and curious
  • Agility/flexibility to changes
  • Solution driven
  • Integrity
  • Caring
  • Teamwork
  • Result-oriented
  • Good communication skills



The Besins Healthcare Pharmtech offer


  • Permanent contract (CDI) ;
  • Full time ;
  • Based in Liège.


Please send your CV and cover letter to job@unid-manufacturing.com


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CMC Team Leader • Liège, Walloon Region, Belgium

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