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:
Scientific/TechnologyAll Job Posting Locations:
Beerse, Antwerp, Belgium, Latina, ItalyJob Description:
About the Department
MSAT Synthetics Drug Product provides end‑to‑end scientific and technical leadership to ensure synthetic solid dosage forms are commercialized and sustained through robust processes, innovative manufacturing technologies, and future-ready lifecycle stewardship.
Individual Contributor
Location: Beerse, Belgium; Latina, Italy; Gurabo, Puerto Rico; Titusville, NJ
Role Purpose
The Fellow, MSAT Synthetics Drug Product Platform is a scientific authority ensuring robust commercialization of synthetic solid drug products, with a primary focus on continuous manufacturing and other advanced process technologies in the space of solid dosage forms.
The role provides technical continuity from late development through commercial manufacturing and across the product lifecycle, ensuring that scientific intent, process architecture, PAT strategies, and regulatory commitments translate into resilient and supply‑reliable commercial execution.
Operating as an individual contributor, the Fellow influences through technical depth, platform and systems thinking, and mentorship.
Key Responsibilities:
Technical leadership
- Provide expert leadership in tablet continuous manufacturing unit operations and other advanced manufacturing technologies.
- Define and review end‑to‑end CM process architectures in alignment with Engineering, Quality, Supply Chain, and platform strategies.
- Track developments in external manufacturing, material, PAT and technology capabilities.
- Guide RTD study design, material traceability, diversion logic, and integration of PAT data into RTRT, PPQ, and CPV frameworks.
- Strengthen JJIM’s CM leadership via intellectual property and scientific communications
Portfolio & Stakeholder management
- Serve as trusted Synthetics DP technology advisor on MSAT Synthetics DP extended leadership team; partner closely with management and SME’s across Synthetics Development (pharmaceutical, chemical and analytical development), MSAT, Global Engineering, Quality, Regulatory Affairs, Value Chain Management, and Supply Chain.
- Champion CM capability building for data, process and material science across development and manufacturing.
- Ensure alignment between product portfolio needs, site capabilities, and supply expectations.
- Act as a technical representative and innovative leader in relevant industry and regulatory fora.
- Function as mentor to partnering functions
Regulatory & CMC Technical Stewardship
- Serve as a senior technical reviewer and contributor for CMC sections related to manufacturing and control strategies.
- Support inspections, health authority interactions, and lifecycle changes with clear, scientifically grounded justifications.
Commercialization and Life Cycle Management
- · Serve as technical steward for the transition into commercial manufacturing preserving process knowledge, assumptions, and design intent across development, transfer, validation, and launch.
- Provide expert input on technology selection, scalability risks, and robustness early in development.
- Guide BP²AL-targets, robust design assessment, product strategy roadmap development
- Provide technical guidance of post‑launch performance to enable commercial improvements
Background & Expertise
- PhD (or equivalent experience) in Pharmaceutical Sciences, Chemical/Biochemical Engineering, or related field with a min of 12 – 15 years of relevant industry and/or academic experience in pharmaceutical development or manufacturing
- · Extensive experience in solid drug product manufacturing processes (direct compression, dry granulation, wet granulation, coating ...), new product & process introduction, continuous manufacturing, PAT, and commercialization
- Regulatory & Quality Credibility: strong experience in development and defense of CMC content for advanced manufacturing technologies. Strong command of global regulatory expectations for continuous manufacturing and PAT based control strategies.
- Core competences: Strategic thinking, Problem-solving, Strong communication written and oral in English language
- · Willigness to travel: 5 – 15%
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Required Skills:
Preferred Skills:
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