Technical Lead

• Execute operations described in Standard Operating Procedures (SOPs) and batch records
• Lead the matrix FLS (frontline support team) a cross departmental team (QA, QC, F&E, IT, MFG, MSAT, SC&L)
• Responsible for schedule adherence, cycle time and issue resolution. Report variances and communicate/mitigate impact to cross functional groups
• Own deviations and leads investigations / CAPA development
• Qualified as a deviation Lead investigator, responsible for medium and high complex investigations across all manufacturing unit operations.
• Lead investigator (medium and complex investigations > technical, compliance and EHSS investigations)
• Qualified trainer for all GMP operations, closed and open operations, including all grade B aseptic handling.
• Owner of GMP documentation, controlled documents and batch records.
• Responsible for manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Solve complex problems; takes new perspectives using existing solutions. Operational trouble shooting
• Production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts as needed
• Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements
• Demonstrate a strong practical and theoretical knowledge in their work and guide team members in issue resolution
• Execute operations described in Standard Operating Procedures (SOPs) and batch records
• Executes transactions and process in all electronic systems
• Demonstrate a strong practical and theoretical knowledge in their work
• Perform tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
• Complete training assignments to ensure the necessary technical skills and knowledge
• Proficient in process systems and supporting business systems setting up manufacturing areas and equipment/fixtures, as needed
• Collaborate with support groups on recommendations and solving technical problems.
• Ensure the shift works effectively in a team based, cross functional environment to complete all production tasks required by shift schedule
• Collaborate closely with Managers to ensure seamless pass down and communication of operational status
• Completes change actions for change controls or investigations
• Initiates and facilitates triage calls
• Identify and propose innovative solutions
• Drive right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving
• Aid in daily work coordination and distribution as demanded through the production schedule
• Ensure shift notes and hand over communication is complete and accurate, as needed
• Leads Tier 1 and Tier 2 meetings
• Delegate for manager
• Drives positive attitude in team

Our Technical Lead perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative, intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented and flexible, with the ability to work effectively and efficiently on a team while demonstrating safety, quality, and GMP compliance at all times., * Associate or bachelor’s degree in related field is preferred.

• A minimum high school diploma and/or equivalent combination of education and experience is required.
• Netherlands
• MBO 3 of 4 in science related field and/or equivalent 4+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
• Extensive knowledge of cGMP regulations and FDA guidance applicable to cell therapy manufacturing
• Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence is highly desired.
• Demonstrated aptitude for engineering principles and manufacturing systems.
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications.
• Demonstrated good interpersonal skills, is attentive and approachable.
• Maintain a professional and productive relationship with area management and co-workers.