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Lead Expert, MSAT Advanced Therapies

Description

MSAT Senior Scientist

Johnson and Johnson Innovative Medicines is hiring for the Advanced Therapies Manufacturing Science and Technology (MSAT) group! We are working to create a world without disease. Changing lives by finding new and better ways to prevent, catch, treat and cure disease inspires us. We bring the best minds together and pursue the most promising science. Are you interested in joining a team that is making a positive impact on patients’ lives by growing and scaling our high-quality cell products, gene therapy and targeted radioligand therapy? Apply today for this exciting opportunity to be part of the team!

Location: Leiden, The Netherlands or Bern, Switzerland.

The Chief Scientist we are looking for is responsible for leading complex, global research and development and coordination projects across the lentiviral vector production network of the Advanced Therapies supply chain for lifesaving drugs life and/or drugs with high unmet medical need. You will also be responsible for Lifecycle Management projects that drive reliability, innovation and sustainability in our processes and plants, internally and externally.

In this role, you will partner with R&D, Quality, and Management to ensure processes meet the needs of today and tomorrow. The Chief Scientist works in close collaboration with other roles and must have strong communication skills to influence other functions/levels outside of the organization itself. In this role you will effectively lead global and cross-organizational teams to achieve the desired results for all parties. A solid understanding of cell and gene production processes is essential. Hands-on experience in both R&D and Manufacturing Operations is highly desirable.

Main Responsibilities:

  • Lead complex and global investigations with cross-functional teams.

  • Liaise closely with manufacturing and field support teams to ensure manufacturing and supply requirements are met.

  • Lead projects that improve manufacturing output through optimization and harmonization across production sites. Your efforts will have a direct impact on patient care!

  • Identify and implement new technologies; focus on reduction of COGs, partner with R&D and JSC groups to develop and implement strategies to improve plant fitment and commercialization of new products into the supply chain.

  • Contribute to, review and approve product technical and management documents (eg, protocols, reports, files, critical analysis, control strategies, master plans, etc.)

Capabilities

Required:

  • University Degree / Bachelor in engineering or Equivalent with 8-10 years work experience. MBA/Master/PhD degree preferred.
  • Detailed technical knowledge of biopharmaceutical manufacturing site unit operations.
  • Ability to influence and lead peers, superiors and external partners.

Preferably:

  • Demonstrated ability and experience managing complex investigations with cross-functional teams.
  • Experience with (lenti)viral vector products and production under Biosafety (BSL-2) conditions.
  • Knowledge of manufacturing site systems and procedures (SAP, incident and complaint handling, change control, certification, Process Validation, Continuous Process Validation, etc.)
  • Demonstrated leadership in providing integration of activities and information across cross functional groups and matrix teams. Organizes, coordinates teams, and establishes and maintains communication with stakeholders and a wider network group.
  • Project management skills; able to effectively introduce deliverables and support execution at the manufacturing site level.
  • Good knowledge of GMP, Quality and Compliance, and regulatory requirements.
  • Self-motivated self-starter able to work independently with proven problem-solving skills.

Other:

  • Fluent in written and spoken English
  • 10-25% travel may be required, depending on project needs

2024-10-22 08:54:00
#Lead #Expert #MSAT #Advanced #Therapies

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