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Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Pharmaceutical Process Operations

Job Category:

Professional

All Job Posting Locations:

Sassenheim, Netherlands

Job Description:

Reporting to the Global Lentivirus Operations Head, the Director Lentivirus Operations will be responsible for all aspects of cGMP operations for a Clinical and Commercial Lentivirus Manufacturing Plant.

The individual will be responsible for the organization build, operations ramp-up and facility approval of an innovative LV manufacturing facility. They will ensure all relevant business processes and effective reporting are established to drive commercial launch and ongoing commercial supply. They will provide leadership to drive effective communication and collaboration across all relevant cross functional groups to ensure robust production and release of product.

The job owner should lead by example and strive to perform to high standards at all times in compliance with Credo and Global Leadership Profile. Act as a role model for all colleagues within Operations and other site departments.

The job owner is responsible to deliver the production output according to the manuacturing production schedule in a Safe- and cGMP compliant manner, striving for operational excellence with high productivity and cost effectiveness and efficiency.

MAJOR RESPONSIBILITIES:

• Provide technical and managerial leadership to drive efficient, compliant, and effective Lentivirus manufacturing operations.

• Build an effective operations and support area teams for clinical and commercial supply of lentivirus vector.

• Developing and driving the operational plan for the ramp up of manufacturing.

• Ownership for regulatory inspection readiness and facility approval

• Supports the introduction of new products and execute the engineering and PPQ runs and manufacturing of clinical lots according to business plan and MPS.

• Provide technical and managerial leadership in all cGMP related areas of responsibility.

• Act as Lentivirus Value Chain Team representative for all Lentivirus operations.

• Ensure that standards for product quality, manufacturing costs and throughput, equipment and employee performance, employee safety and housekeeping standards are established, monitored, and maintained.

• Develop and drive the operational plan for the ramp up of manufacturing.

• Drive a collaborative work environment that focuses on creating and maintaining a strong quality and continuous improvement culture within the organization.

• Build and execute on the training and qualification (aseptic & process) plan of the team.

• Build a strategy to develop existing talent through broadening experiences and commitment to delivery to the highest standards. Continue to build bench strength in entire operations organization and ensure robust succession planning.

QUALIFICATION:

• Minimum 15 years of combined experience in cGMP manufacturing, operations management, tech transfer, process and equipment validation, and quality management

• Minimum of 10 years of experience in a leadership role in Biologics and/or cell therapy operations

• Proven experience in Lentivirus manufacturing.

• Strong leadership and communication skills.

• Good English languages skills, both in writing and verbal

• Deep understanding of cGMP regulations and quality systems.

• Strategic mindset with the ability to drive operational excellence.

• Experience in a growth environment managing the fast pace of change, balancing day to day operational demands with the need to extend and improve the planning horizon to prepare for tomorrow.

• A history of developing and building cohesive, high performing teams with a strong sense of mission, providing training, and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning

• Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels

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