Description
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 MedTech, 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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Supply Chain EngineeringJob Sub Function:
Process EngineeringJob Category:
People LeaderAll Job Posting Locations:
Beerse, Antwerp, Belgium, Schaffhausen, SwitzerlandJob Description:
MSAT Synthetic Manufacturing Drug Substance – Cleaning Sciences
Locations: Beerse, Geel (Belgium), Basel, Allschwil, Schaffhausen (Switzerland), Cork (Ireland), Athens, GA (USA)
About Johnson & Johnson Innovative Medicine
At Johnson & Johnson, we believe health is everything. Through our Innovative Medicine and MedTech platforms, we deliver breakthrough therapies that transform patient lives worldwide. We value diversity of thought, foster inclusion, and support people in reaching their full potential.
For more than 130 years, diversity, equity & inclusion (DEI) has been part of our culture at Johnson & Johnson. Rooted in Our Credo, DEI strengthens belonging, fuels innovation, and helps us better understand and meet the needs of the communities we serve. We foster an inclusive environment where different perspectives are valued, and our people can thrive and reach their full potential.
Role Summary
The MSAT Synthetic Drug Substance Fellow – Cleaning Sciences is a global, senior scientific leadership role within the MSAT Synthetic Drug Substance platform.
This role strengthens platform-wide synthetic drug substance cleaning sciences capability across a complex, multi-product manufacturing network, supporting increasing compound potency, portfolio complexity, and global regulatory expectations.
The Fellow serves as the global technical authority for synthetic drug substance cleaning sciences, providing scientific leadership, lifecycle stewardship, and external advocacy. The Fellow collaborates closely with internal & external manufacturing site cleaning sciences teams that execute cleaning lifecycle activities and cleaning validation.
Key Responsibilities
Scientific Leadership
- Set global technical direction for synthetic drug substance cleaning sciences and resolve complex, high-impact issues
- Provide expertise in cleaning chemistry and cross-contamination risk management to set science-based residue limits and controls
- Steward science‑based principles and technical positions for cleaning strategies across the global network to drive consistent, compliant decisions
- Consult on novel, high‑complexity, or precedent‑setting scenarios (e.g. high‑potency compounds, new chemical classes, complex equipment trains) to enable timely decisions and risk mitigation
- Benchmark best practice in the sustainability aspects of cleaning
Cleaning Validation & Lifecycle Strategy
- Steward global cleaning validation frameworks aligned with ICH guidelines to enable consistent, inspection-ready approaches
- Apply lifecycle thinking across validation, continued verification, and re-validation to sustain control and drive continuous improvement
- Set global, risk-based principles for worst-case selection, sampling approaches, and analytical strategy to enable standardized, science-based acceptance criteria across sites
- Serve as the technical escalation point for complex cleaning-related changes, deviations, and investigations to ensure scientifically sound root-cause conclusions and effective CAPA
Proactive Lifecycle Cleaning Readiness
- Drive proactive cleaning readiness with R&D cleaning experts, tech transfer, and sites across commercialization readiness and post-launch lifecycle to de-risk commercialization and subsequent changes
- Embed cleaning criteria in tech transfer and lifecycle change assessments to enable right-first-time validation and sustained control at sites
- Define cleaning maturity and compliance-risk criteria to inform supplier selection, and support the uplift of supplier capability in cleaning sciences, as needed
Cross-Functional, Technology & External Engagement
- Partner with cross-functional stakeholders (R&D, Engineering, Quality, Impurity Management, Tox, EHS) to align cleaning strategy and accelerate adoption of proven and emerging cleaning technologies
- Drive adoption of global synthetic drug substance cleaning technical positions and lessons learned across sites to standardize best practices and execution
- Representing J&J in industry and scientific forums to shape external thinking and stay current on evolving expectations
Capability Building
- Steer network-wide synthetic drug substance cleaning science capability priorities to strengthen technical decision quality
- As a core member of Cleaning Sciences CoP (Community of Practice), provide technical governance for global guidance and learning assets to enable consistent application across sites
- Enable technical peer review and knowledge sharing to accelerate learning and standardize best practices
Qualifications
Education:
- Enable technical peer review and knowledge sharing to accelerate learning and standardize best practices
Experience:
- 15+ years of experience in pharmaceutical manufacturing/MSAT/technical operations, with deep expertise in synthetic drug substance manufacturing operations and a strong understanding of interdependencies with cleaning science and validation
- Demonstrated ability to set or govern global technical standards/strategies and influence decisions across sites without direct authority
- Proven track record in supporting regulatory inspections and responding to complex technical questions related to cleaning and contamination control
- Experience partnering cross-functionally (e.g., Quality, Engineering/GET, Toxicology, EHS) to deliver risk-based, compliant outcomes
- External scientific engagement (e.g., publications, conferences, industry consortia/working groups) preferred
What Success Looks Like
- Cleaning readiness enabled through partnership with R&D and site cleaning experts across commercialization readiness, tech transfer, and lifecycle changes to reduce late rework and validation delays
- Global cleaning strategies and technical positions applied consistently across sites to strengthen inspection readiness and compliance
- Complex cleaning decisions resolved efficiently through clear standards and expert escalation support to improve right-first-time execution
- Cleaning capability and technology adoption, including emerging technologies, kept current with industry advances and evolving regulatory expectations to enable robust, efficient manufacturing
Required Skills:
Preferred Skills:
Agile Decision Making, Consulting, Crisis Management, Developing Others, Disruptive Innovations, Emerging Technologies, Inclusive Leadership, Leadership, Lean Supply Chain Management, Manufacturing Standards, Process Control, Process Engineering, Process Improvements, Product Costing, Program Management, Project Schedule, Resource Planning, Science, Technology, Engineering, and Math (STEM) Application, Stakeholder Engagement, Technical Research