Manufacturing Supervisor

Location Belgium
Discipline: Biotechnology
Job type: Temporary/Freelance
Contact name: Garreth Koslowski

Contact email: g.koslowski@panda-int.com
Job ref: 20122
Published: about 2 months ago
For a major client in the Biotechnology sector in Belgium, we are searching for a Manufacturing Supervisor. In this role you will ensure that the facilities and team are built in line with manufacturing needs, complete manufacturing plant projects with current focus on process and procedures according to regulatory, quality and business requirements, as well as liaise with external suppliers.

Responsibilities:
Lead projects linked to Houston manufacturing readiness within agreed URS, timelines and budgets:
 
  • Prioritize projects and prepare proposal to Manufacturing Leadership team
  • Define and implementation plan for all projects
    • Define resources & capex allocation (people, budget)
    • Define milestones, implement, and follow up indicators
  • Deliverable:
    • Pre-Clinical & Clinical grade manufacturing ready to operate
    • HR structure in line with manufacturing needs

Build and Lead project and manufacturing team:
 
  • Build a highly performant team that will achieve Belgium manufacturing objectives
  • Set highly ambitious and clearly prioritized vision to the team
  • Provide clear direction and define priorities and goals to the teams. Ensure clear roles and responsibilities on an individual but also team level. Set priorities in accordance with the Belgium manufacturing objectives.
  • Listen to the different voices and win the commitment of team members. Provide guidance and favor empowerment
  • Encourage continuous improvement initiatives and dedication to safe workplace practices.
  • Organize regular face to face and project meetings to monitor project and people motivation
  • Provide leadership demonstrating values of integrity, courage and patience and promote staff engagement and development


Stakeholder management:
External stakeholders:
  • Manage third parties, contractors, to achieve Houston Manufacturing readiness in line with corporate objectives and with high quality and on schedule:
    • Set up technical specifications
    • Analyze offers
    • Contribute to the selection of suppliers and subcontractors
    • Coordinate implementation with regards to sub-contractors, internal resources, and other projects, to get quality deliverables on time
    • Ensure follow up of implementation until final acceptance of work
    • Solicit and respond to users ‘input with the team members and maintain positive relationships with all internal and external stakeholders
    • Define a schedule to internalize staff

Internal stakeholders:
  • Make different teams (QA, QC, business, production, logistics, maintenance, HR, etc.) work together to focus on the same strategic objectives
  • Set efficient communication, escalation, and cascade channels
  • Communicate regularly on the completion of objectives and main achievements
  • Delegate the right level of responsibility to team members to empower them
  • Ensure smooth launch and continuous improvement of activities (facilities and equipment)
    • Collaborate with other departments
    • Define and supervise FAT and SAT
    • Lead, supervise, and manage the Houston manufacturing team
    • Build a strong Houston manufacturing team
    • Benchmark and implement good practices in a continuous improvement mindset, and reengineer processes where needed
    • Manage assets of building and facilities, including administrative, QA/QC, warehouse, process development, and GMP manufacturing facilities
  • Ensure technical feasibility and adequacy to meet business needs through interaction with the engineering team, with a focus on enabling compliance and manufacturing readiness
    • Strengthen in-house capabilities, identify gaps, and develop solutions to meet business needs
    • Recruit and maintain staff to build a first-class facility to lead the leukapheresis business, with HR support
    • Develop process and compliance excellence in line with QA/RA requirements

Ensure smooth launch and continuous improvement of activities (facilities and equipment)
  • Collaborate with other departments
  • Define and supervise FAT and SAT
  • Lead, supervise, and manage the Houston manufacturing team
  • Build a strong Houston manufacturing team
  • Benchmark and implement good practices in a continuous improvement mindset, and reengineer processes where needed
  • Manage assets of building and facilities, including administrative, QA/QC, warehouse, process development, and GMP manufacturing facilities

Ensure technical feasibility and adequacy to meet business needs
  • Interact with the engineering team to enable compliance and manufacturing readiness
  • Strengthen in-house capabilities, identify gaps, and develop solutions to meet business needs
  • Recruit and maintain staff to build a first-class facility to lead the leukapheresis business, with HR support
  • Develop process and compliance excellence in line with QA/RA requirements
Your Profile:
  • BS required or equivalent combination of education and experience.
  • 7+ yr.’s experience in a related manufacturing environment (cell therapy or biotech) required.
  • 1+ yr.’s operating at a supervisor level or above.
  • Previous experience with standard cleanroom equipment: Incubators, BSCs, and Centrifuges preferred.
  • Previous experience with the following Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Waves/Xuris, Incubators, Cell Stacks, Cobes, or Lovos preferred.
  • Meticulous attention to detail required in terms of documentation, following procedural SOPs, and performing functions as it pertains to the Batch Record.
  • Previous experience quthoring and revising SOPs and batch records preferred.
  • Proficient with Microsoft Office: Word, Excel, and Outlook.
  • Previous GMP Experience required.

DISCLAIMER

The above job description is not an exhaustive list of all duties and responsibilities of the position and in no way, is to be construed as a contract.