CMC Production Supervisor

UniD is a Contract & Development Manufacturing Organization dedicated to long acting implants for the controlled release of drugs. Its brand-new facility with its tailormade equipment & technologies allows to handle extrusion, co-extrusion as well as injection moulding-based products. Clients can benefit from unique services going from Proof of Concept to commercial manufacturing.

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

To lead the day-to-day operational execution of CMC manufacturing and development trials activities in adherence with UniD’s global planning, UniD is hiring a CMC Production Supervisor.

Your responsibilities

  • The CMC Production Supervisor is responsible of the following:
  • 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 planning to achieve departmental and site objectives.
  • Ensure a smooth/efficient workflows and execution coordination 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 and change controls.
  • Promote a quality and performance mindset within all CMC areas activities.
  • 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 cGMP regulated environment
  • Minimum of 2 years of supervisory experience
  • Experience in the pharmaceutical industry, ideally in a CDMO environment
  • Strong interpersonal communication skills and ability to thrive in a dynamic team environment
  • Organizational and leadership skills with ability to effectively delegate work
  • Ability to prioritize and flexibility to adapt to changing business schedules and deadlines
  • 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
  • Influence, persuasion, and or change management
  • Lean or similar continuous improvement methodologies is a plus
  • Position may require employees to work shifts, holidays, and weekends
Your profile

What we offer

  • A permanent position in an innovative and dynamic and fast-growing company.
  • A fulltime job
  • Location in Liège
What we offer