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Johnson & Johnson Innovative Medicine are recruiting for a MSAT Biotherapeutics Drug Product Fellow Aseptic and Sterile Manufacturing to be based in Schaffhausen, Switzerland or Titusville, US or Beerse, Belgium.

As an MSAT Biotherapeutics Drug Product Fellow Aseptic and Sterile Manufacturing, 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 and health authorities to develop and implement robust and holistic aseptic manufacturing strategies for J& Js internal sites and external Network to meet the emerging and future needs of JNJ` s portfolio.

You will share in depth expertise in aseptic manufacturing, provide guidance on compliance aspects and shape global concepts to deliver on 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 parenteral Large Molecule Biotherapeutics Drug Products.
• In conjunction with other key experts and partners to develop and deploy a JJIM enterprise methodology on a Gravel-to-Grave process on robust aseptic manufacturing.
• Subject Matter Expert (SME) in the global MSAT organization to cover needs for LM and parenteral products with regard to aseptic manufacturing processes, sterilization technologies and related processes.
• Shape and continuously improve communities of practices by sharing outstanding knowledge around critical sterile manufacturing practices and concepts across different platforms within JJIM.
• Proactively promote quality and compliance in the areas of sterile manufacturing and validation and mentor others to do the same.
• Develop and launch innovative concepts for sterile manufacturing technologies by focusing on quality by design and future prospective compliance.
• Collaborate with skilled and diverse teams across the global LM network providing knowledge, strategic leadership and direction across JJIM supply chain.
• Provide technical support to regulatory filings, regulatory inspections, and health authority questions.
• Collaboration in technology transfer projects supporting implementation of new processes in manufacturing operations.
• Participate in industry conferences, shape opinions on aseptic processes and technologies and collaborate with heath authorities or regulators to launch innovative concepts.

Specific knowledge

• Strong expertise (at least 10 years) on pharmaceutical manufacturing processes and products, equipment with focus on low bio-burden and sterile manufacturing.
• Proven understanding (minimum 5 years) of Quality & Compliance / regulatory requirements (GMP) especially for sterile production.
• Project management, organizing, planning and coordination skills.
• In depth knowledge on Annex 1 guidelines.

Personal and interpersonal skills

• Ability to shape opinions in cross-functional teams
• Leadership experience (10+ years) in multicultural teams
• Ability to manage complexity and change
• Ability to interact at different levels of the organization.
• Ability to handle conflicting interests and take decisions
• Customer and team focus for value creation
• Ability to work under pressure, handle conflicting interests, and take decisions

Personal attitude and mentality

• Drives for innovation and change to ensure competitiveness
• Can-do mentality, agility & flexibility and able to work with stretched goals
• Willing to place the goals of the team first and work with others towards these goals
• Communicative / Motivator / Negotiator / assertive person having impact
• Showing a high sense of responsibility regarding professional activities

Good Manufacturing Practices (GxP)

• Adhere to applicable cGxP’s and procedures (role model)
• Report incidents and deviations
• Proposing solution to improve compliance with cGMP’s

Education:

• Bachelor of Science degree required
• Master' s or advanced degree in a scientific field (Life Science, Pharmacy or Engineering) is desirable.

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