Fellow Continuous Manufacturing Solids

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About the Department

MSAT Synthetics Drug Product provides endtoend 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 supplyreliable 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 endtoend 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 JJIMs 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 SMEs 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 postlaunch 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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The anticipated base pay range for this position is :

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