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 (https://www.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:** Discovery & Pre-Clinical/Clinical Development **Job Sub** **Function:** Pharmaceutical Product R&D **Job Category:** Scientific/Technology **All Job Posting Locations:** Beerse, Antwerp, Belgium **Job Description:** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine The Global Pharmaceutical Product Development and Supply organization (PPDS) is within the Discovery, Product Development and Supply (DPDS) organization of Johnson and Johnson Innovative Medicine (JJIM) responsible for the development of Pharmaceutical Dosage Forms with development centers being located in the US, Asia and Europe. For the location in Beerse, Belgium there is a vacancy for a **Senior** **Principal Scientist, Oral Solids Development.** At JJIM we strive to improve life and outcomes of millions of patients worldwide. Do you want to be a true pioneer and join us in our journey towards the development of innovative therapeutics delivered orally? Then seize this opportunity and join JJIM. In the Oral Solids Development department in Beerse, Belgium, we are looking for an enthusiastic and dedicated colleague who shares our ambition to develop break-through products. **Overall Mission** Lead the end‑to‑end **formulation and continuous process development** for oral solid dosage forms within the PPDS group (Beerse, Belgium). The role emphasises cross‑functional leadership, deep scientific and engineering expertise in **continuous manufacturing (CM)** , and a strong innovation and customer focus. A key objective is to define and implement CM strategies (unit operations, PAT, control and data architecture) aligned with JJIM’s commercial capabilities and our Continuous Manufacturing Platforms. **About the Department** **Oral Solids Development (OSD)** is a 45+ member, multi‑national team dedicated to developing high‑quality oral solid dosage forms and driving innovation across a broad range of small‑molecule and emerging therapeutic modalities. The group is expanding **continuous processing** capabilities, integrating **process analytical technology (PAT), advanced modelling and control** , and **digitalisation** to accelerate development‑to‑commercial transitions. **Specific Responsibilities** **Leadership & Cross‑Functional Stakeholdering** + Serve on the OSD extended leadership team; partner closely with PPDS Scientific Integration, JJIM Supply Chain, Quality, Pharmaceutical & Material Sciences, Analytical Development, API Development, Portfolio Management, Clinical Supply Chain and site/global functions. + Champion CM ways of working, capability building, and change management across development and manufacturing. **CM Strategy, Platforms & Innovation** + Define and evolve the OSD **Continuous Manufacturing Technology Platform** including **modular skids, PAT ports, material traceability strategy, and data architecture** . + Drive innovation in **Real‑Time Release Testing (RTRT)** , **advanced process control (APC)** , and **model‑informed product & process development (MIPD)** ; pilot digital twins where impactful. **Process & Formulation Development (End‑to‑End CM)** + Translate Target Product Profile (TPP)/CQA into **process options and control strategies** for CM: + Build **robust start‑up, steady‑state and shutdown** , **diversion strategy** , and **state‑of‑control criteria** . **RTD Modelling, Material Traceability & Disturbance Management** + Design and execute **residence time distribution (RTD)** studies + Build RTD‑based **material traceability** , implement **diversion windows** . + Couple RTD with **first‑principles/empirical sub‑models** to support **design space** and **RTRT** justification. **Regulatory, GMP & Validation for CM** + Author high‑quality **development reports, control strategy justifications, RTD/traceability dossiers, model validation packages, CPV plans** , and **responses to Health Authorities** specific to CM (including state‑of‑control and material traceability arguments). + Define **PPQ in a continuous context** , including run length, challenge tests, model performance verification, and **Continued Process Verification** using Multivariate Statistical Process Control and on‑going PAT monitoring. **Tech Transfer, Launch & Lifecycle** + Lead CM tech transfer to clinical/commercial assets: equipment mapping, PAT portability, model re‑calibration/transfer, performance qualification, **recipe standardisation** , operator training and readiness. + Monitor commercial performance, oversee **model and control strategy maintenance** , and drive lifecycle changes through formal change control. **External Collaboration & IP** + Build collaborations with **equipment vendors, PAT suppliers, academic consortia** ; execute **feasibility studies** to de‑risk new equipment and control concepts. + Partner with Legal/Procurement/IP to manage external engagements and protect emerging **know‑how and patents** in CM and RTRT. **Scientific & Patent Intelligence; Communication** + Continuously review scientific and patent literature to identify **next‑gen CM technology, PAT, hybrid modelling, APC** and **digital twin** opportunities. + Contribute to **internal/external publications** and **conference presentations** that demonstrate CM leadership. **Key Deliverables & Metrics (Examples)** + Approved **CM control strategy** including **RTD‑based diversion logic** and **RTRT** . + Validated **PAT models** (calibration/validation/maintenance plan) and **APC** schemes with defined state‑of‑control metrics. + Signed **design space** and **CPP/PARs** supported by DoE + modelling. **Your profile** Ph.D. in Pharmaceutical Sciences, Industrial Pharmacy, Biochemical Engineering, Chemical Engineering, Biological or Physical Sciences or Equivalent by experience with a Bachelor or Master Degree in the Relevant Areas. At least 6 years of relevant industrial experience or equivalent with a demonstrated competency and experience in oral solids continuous manufacturing development within the pharmaceutical industry is required. Experience in defining and managing development activities at an external CRO is a plus. **Assets** **Leadership & Collaboration** + Strong ability to work across functions and build relationships with partners in Supply Chain, Quality, Analytical Development, API Development, and global manufacturing. + Comfortable leading without direct authority and driving adoption of new ways of working. + Effective at communicating complex topics in a clear, approachable way. **Continuous Manufacturing Expertise** + Experience working with continuous processing equipment such as feeders, continuous blenders, twin‑screw granulators, dryers, and tablet presses. + Understanding of how to design stable continuous processes and manage start‑up, steady‑state, and shutdown conditions. **Innovation & Technical Problem‑Solving** + Familiarity with advanced tools such as Real‑Time Release Testing (RTRT), process automation/control systems, and data‑driven approaches like digital twins or model‑based development. + Ability to identify and implement new technologies that improve efficiency, reliability, and product quality. **Analytical & Modelling Skills** + Ability to use analytical tools and process models (e.g., residence time distribution studies) to understand process behavior and ensure consistent product quality. + Experience with data analysis, trend monitoring, and linking process parameters to product quality. **Regulatory & GMP Understanding** + Experience preparing scientific documents, technical justifications, and regulatory materials. + Working knowledge of GMP requirements and expectations for validating and monitoring continuous processes. **Technology Transfer & Lifecycle Management** + Ability to transfer processes into manufacturing environments, ensuring equipment alignment, operator training, and readiness for launch. + Comfortable supporting ongoing commercial performance and continuous improvement. **External Engagement & Scientific Awareness** + Experience collaborating with equipment vendors, technology partners, and academic groups. + Awareness of emerging trends, new technologies, and the intellectual‑property landscape. + Willing and able to travel internationally (5–15%). **What We Offer** + The opportunity to shape next‑generation oral solid manufacturing platforms. + A highly collaborative, international environment with strong scientific depth. + Access to state‑of‑the‑art CM equipment, digital tools, and development facilities. + Career growth through scientific leadership, innovation projects, and global cross‑functional exposure. If you’re passionate about transforming pharmaceutical manufacturing and driving innovation in continuous processing, we’d love to hear from you. **Required Skills:** **Preferred Skills:** Budget Management, Chemistry, Manufacturing, and Control (CMC), Clinical Trial Protocols, Drug Discovery Development, Industry Analysis, Interdisciplinary Work, Market Research, Pharmacokinetic Modeling, Process Improvements, Product Development, Product Licensing, Product Strategies, Risk Management, Scientific Research, Standard Operating Procedure (SOP), Tactical Planning, Technical Credibility