Sr Principal Scientist Pharma Prod RD

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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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 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 withdevelopment 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 endtoend formulation and continuous process development for oral solid dosage forms within the PPDS group (Beerse Belgium). The role emphasises crossfunctional 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 JJIMs commercial capabilities and our Continuous Manufacturing Platforms.

About the Department

Oral Solids Development (OSD) is a 45 member multinational team dedicated to developing highquality oral solid dosage forms and driving innovation across a broad range of smallmolecule and emerging therapeutic modalities. The group is expanding continuous processing capabilities integrating process analytical technology (PAT) advanced modelling and control and digitalisation to accelerate developmenttocommercial transitions.

Specific Responsibilities

Leadership & CrossFunctional 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 RealTime Release Testing (RTRT) advanced process control (APC) and modelinformed product & process development (MIPD); pilot digital twins where impactful.
  

Process & Formulation Development (EndtoEnd CM)

• Translate Target Product Profile (TPP)/CQA into process options and control strategies for CM:
• Build robust startup steadystate and shutdown diversion strategy and stateofcontrol criteria.

RTD Modelling Material Traceability & Disturbance Management

• Design and execute residence time distribution (RTD) studies
• Build RTDbased material traceability implement diversion windows.
• Couple RTD with firstprinciples/empirical submodels to support design space and RTRT justification.
  

Regulatory GMP & Validation for CM

• Author highquality development reports control strategy justifications RTD/traceability dossiers model validation packages CPV plans and responses to Health Authorities specific to CM (including stateofcontrol 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 ongoing PAT monitoring.
  

Tech Transfer Launch & Lifecycle

• Lead CM tech transfer to clinical/commercial assets: equipment mapping PAT portability model recalibration/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 derisk new equipment and control concepts.
• Partner with Legal/Procurement/IP to manage external engagements and protect emerging knowhow and patents in CM and RTRT.
  

Scientific & Patent Intelligence; Communication

• Continuously review scientific and patent literature to identify nextgen 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 RTDbased diversion logic and RTRT.
• Validated PAT models (calibration/validation/maintenance plan) and APC schemes with defined stateofcontrol 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 twinscrew granulators dryers and tablet presses.
• Understanding of how to design stable continuous processes and manage startup steadystate and shutdown conditions.

Innovation & Technical ProblemSolving

• Familiarity with advanced tools such as RealTime Release Testing (RTRT) process automation/control systems and datadriven approaches like digital twins or modelbased 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 intellectualproperty landscape.
• Willing and able to travel internationally (515%).

What We Offer

• The opportunity to shape nextgeneration oral solid manufacturing platforms.
• A highly collaborative international environment with strong scientific depth.
• Access to stateoftheart CM equipment digital tools and development facilities.
• Career growth through scientific leadership innovation projects and global crossfunctional exposure.

If youre passionate about transforming pharmaceutical manufacturing and driving innovation in continuous processing wed love to hear from you.

Required Skills:

Preferred Skills: