Fellow Continuous Manufacturing Solids

Johnson & Johnson•Titusville, NJ

1d•Onsite

About The Position

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.

Requirements

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
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.
Strategic thinking
Problem-solving
Strong communication written and oral in English language
Willigness to travel: 5 – 15%

Responsibilities

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
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
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.
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