CMC Team Leader

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.

Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match.

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. xirbnpk
• 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