Process Investigation Lead
il y a 20 heures
Janssen Pharmaceutica is recruiting for Process Investigation Lead in the Manufacturing Excellence CAR-T EMEA, located in Ghent Belgium.
The Manufacturing Excellence CAR-T EMEA organization is an organization which provides and supports a high degree of assurance that specific processes will consistently produce and meets its pre-determined specifications by deploying process validation, process system engineering, data architecture and continuous process verification and process investigation.
The Process Investigation Lead is the role for providing quality investigation oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GxP environment
**Key Responsibilities**
- The role includes managing, reporting and reviewing manufacturing investigations, ownership of various departmental post-implementation optimizations and tracking of quality metrics while ensuring high quality and compliant product supply.
- Collaborate with site personnel to provide guidance and determine resolution for manufacturing process issues.
- Ensure accurate review of manufacturing investigations, CAPAs, change controls and complaints.
- Perform analysis on quality indicating data and identifying trends.
- Collaborates on high-level with functional departments to resolve issues.
- Manage cross-functional optimizations with many stakeholders as outcome of the investigation process.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Require mínimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with manager for
decisions outside established processes.- Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
- Routinely recognize and resolve quality issues. Seek management guidance on complex issues.
- Drive continuous improvement.
**Qualifications**:
- A minimum of Master’s degree in Molecular Biology, Cell Biology, Biochemistry or related area in the Life Sciences is required. A PhD in the afore mentioned areas is preferable.
Required:
- Strong working knowledge of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
- A minimum of 5 years relevant work experience working in a controlled, cleanroom environment under aseptic conditions is required, preferably in a
manufacturing compliance, clinical quality or quality assurance area.- Experience in an industrial manufacturing or regulated environment is required
- The individual will be the SME for process investigation reporting and will partner closely with our partner Legend BioTech, the quality organisations and
Technical Subject Matter Experts (SMEs)- Good people management and strong technical skills and the ability to work well under pressure
- The Investigation lead will build and develop an effective team for process investigation on clinical production and will strategically prepare for commercial supply of a CAR-T product.
- Ability to summarize, report and present results, and experience with team-based collaborations is a requirement.
- The individual will lead, direct and coach this team.
- The individual will contribute to business integrated schedules in partnership with Advanced Therapies team and translate business goals into team objectives together with the Director Manufacturing Excellence, CAR-T EMEA
- The individual will actively participate in all regulatory and internal audits of the process and facility
- Actively execute the company’s prevention strategy Safety, Health and Environment (SHE)
Preferred:
- Specific field experience with quality business systems (TrackWise /LIMS) is preferable
- The individual will communicate effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best
- Other:
- Ability to quickly process complex information and often make critical decisions with limited information.
- Ability to pay attention to details and follow the procedures.
- Good written and verbal communication skills are required.
- Ability to work with others in a team environment.
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP)
- Ability to identify/remediate gaps in processes or systems.
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