Johnson & Johnson Innovative Medicine are recruiting for a Director MSAT LM Cross Platform Engineering to be based in Schaffhausen, Switzerland or Leiden, The Netherlands or Beerse, Belgium.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.

As a Director MSAT LM Cross Platform Engineering, you will hold a strategic role within Global MSAT and will partner with R&D, Make functions, New Product Introduction, the Quality Organization and Value Chain Management teams, as well as internal manufacturing sites, external partners, such as contract manufacturing organizations, to develop and implement robust manufacturing processes.

You will lead a team of 8+ Engineers to deliver short-to-long term pipeline of initiatives associated to Johnson & Johnson large molecule and parenteral product strategy and grow.
Key Responsibilities:

• Responsible for strategic framework around LM DP parenteral products
• In conjunction with other key disciplines to develop and deploy a JJIM enterprise methodology on a Gravel-to-Grave process on robust aseptic manufacturing
• Single Point of Contact (SPOC) for MSAT needs for LM and parenteral products with regard to aseptic manufacturing processes, sterilization technologies, visual inspection, validation and continued process verification.
• Manage communities of practices and know-how around critical sterile manufacturing practices like sterilization technologies, aseptic manufacturing, visual inspection and life cycle process validation (CPV) within the firm
• Proactively promote quality and compliance in the areas of sterile manufacturing and validation and coach others to do the same.
• Manage a highly engaged MSAT team providing strategic leadership and direction aligned with the global LM network.
• Oversee technical support to regulatory filings, regulatory inspections, and health authority questions.
• Collaboration in technology transfer projects supporting implementation of new processes in manufacturing operations
• Lead and supervise a team of engineers and scientist. Coach, develop and guide team towards company, platform and team goals & objectives

Qualifications

• Strong expertise in pharmaceutical manufacturing processes, with a focus on low bio-burden and sterile manufacturing
• Knowledge of Quality & Compliance/regulatory requirements (GMP) for sterile manufacturing
• Proficient in process excellence methodologies such as Six Sigma and experienced in project management
• Demonstrated ability to lead cross-functional/cross-regional project teams effectively and experience in direct team leadership
• Strong interpersonal skills with the ability to manage complexity, adapt to change, and interact at different levels of the organization.

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