Fellow, Drug Product - Manufacturing Sterile Products

Johnson & Johnson seeks a Senior Fellow in Drug Product Manufacturing for sterile products in Schaffhausen. This strategic role partners with global teams to advance aseptic manufacturing strategies for biotherapeutics.

This position sits within the Global MSAT group and serves as a strategic partner to R&D, Make, Quality, and Value Chain divisions. The primary purpose is to define and execute aseptic manufacturing strategies for sterile biotherapeutics, thereby supporting the delivery of critical life-saving medicines and shaping the future of production methods.

Responsibilities

• Establish and manage the strategic framework for parenteral Biotherapeutics Drug Products, ensuring robust sterile manufacturing methodologies are deployed across the enterprise.
• Act as the global Subject Matter Expert for Biotherapeutics and parenteral products, providing guidance on aseptic processing, visual inspection, and container closure integrity.
• Enhance communities of practice by disseminating knowledge regarding critical sterile manufacturing techniques and best practices.
• Champion quality standards and regulatory compliance in sterile manufacturing and validation, while mentoring colleagues on these topics.
• Create and implement innovative sterile manufacturing technologies, emphasizing a Quality by Design approach.
• Provide strategic leadership and technical expertise to the global Biotherapeutics network.
• Support regulatory filings, inspections, and responses to health authority inquiries with technical data and expertise.
• Facilitate technology transfer projects to ensure the smooth implementation of new processes within manufacturing operations.
• Engage with industry conferences, shape industry opinions, and collaborate with regulators and health authorities.

Requirements

• Hold a Bachelor’s degree or equivalent qualification.
• Possess at least 10 years of relevant professional experience.
• Demonstrate deep expertise in pharmaceutical manufacturing, including sterile processes, visual inspection, and container closure integrity.
• Show a solid understanding of Quality & Compliance standards and regulatory requirements, particularly GMP.
• Exhibit strong project management abilities, including planning, organization, and coordination.
• Have in-depth knowledge of FDA guidelines, ANNEX1, and Good Manufacturing Practices (GxP).
• Prove ability to influence and align cross-functional stakeholders across various organizational levels.
• Handle complexity, ambiguity, and change effectively, making sound decisions under pressure.
• Maintain a strong focus on customer and team orientation, consistently driving value creation.
• Show a track record of fostering innovation and continuous improvement to enhance competitiveness.
• Display agility, flexibility, and resilience, performing well in environments with challenging goals.
• Possess excellent communication, motivation, and negotiation skills, with the ability to assert ideas and create impact.
• Demonstrate proficiency in English, with excellent written and verbal communication skills.

Nice to have

• Master’s or advanced degree (PhD) in Life Science, Pharmacy, or Engineering.
• Experience leading global, multicultural teams.
• Training or certification in Lean, Six Sigma, or Process Excellence.
• Proficiency in German, Dutch, or Flemish.

What the company offers

• A flexible work policy requiring a minimum of three days on-site per week, with two days available for remote work.
• The opportunity to make a meaningful impact by developing treatments and finding cures for complex diseases.

About the company

Johnson & Johnson operates with the belief that health is paramount, aiming to build a world where complex diseases are prevented, treated, and cured. The company fosters an inclusive environment that respects diversity and dignity, treating every individual with respect.

• Commitment to preventing, treating, and curing complex diseases.
• Inclusive work environment that values diversity and individual dignity.