Description

Leiden site Manufacturing Science & Technology (MSAT) is part of the global Janssen Supply Chain MSAT organization. We manage the technology platform strategy within our Leiden manufacturing site, supporting Large Molecule, Lentivirus and Viral Vector production.

At MSAT, we are responsible for the validation and standardization of Equipment for New Product Introduction and process validation activities for the Life Cycle Management (LCM) of commercial products. The Process Analytics team tests and implements new process (analytical) technology (PAT), owns the technical expertise for process modeling, and drives the adoption of this on-site. We strive for hands-free, fully automated, continuous biopharmaceutical production processes!

To accelerate the deployment of PAT, realize value, and sustain implemented technologies, we want to strengthen our team with a Senior Associate Scientist in Process Analytics.

General Responsibilities:

As a Process Analytics Scientist at MSAT, your key responsibility is to lead or support the execution of PAT projects, and to pioneer new technological or process modeling solutions to further build our site innovation strategy and roadmap! You are the primary interface between global innovation teams, Operations, R&D, Automation, and Quality.

• As the site lead for one of our key PATs: Raman spectroscopy, you will explore and assess Raman application opportunities, support the scale out of Raman, and establish a plan to sustain the technology on-site.

• Together with R&D, the Technical Launch Integrator, Operations, and Regulatory Affairs you will define the Raman implementation strategy for new product introductions and commercial products on-site

• Develop and validate Raman chemometric models for use in our GMP manufacturing processes and maintain them throughout their lifecycle

• Develop and sustain multi-variate analysis process models (real-time monitoring, advised future) and integrate Raman models within these

• Lead key MSAT strategic projects in the areas of continuous manufacturing, process modeling, and real-time release

• Carry out all activities in compliance with J&J and cGMP/EHS regulatory requirements

• Support other activities in the team and work area according to appropriate procedures, values, and standards on an ad-hoc basis as the need arises

Qualifications

Education:

• Bachelor’s degree or higher in either Data Science, IT, Microbiology, Biochemistry, Pharmacy, Biotechnology, Science, Innovation, Engineering or equivalent

Experience and Skills:

Required:

• Senior Associate Scientist: 4+ years of meaningful work experience with BSc, 3+ years with MSc or advanced degree EngD/Ph.D or equiivalent.

• Project & change management

• Experience with modeling software, e.g., SIMCA, Simio, Python, R;

• Knowledge of and hands-on experience using standard statistics, and generating useful scientific conclusions

Preferred:

• (Biopharmaceutical) Manufacturing experience within a GMP-regulated environment

• Experience of Raman Spectroscopy, other PAT, and spectral data analysis

• Experience in building data pipelines (Databricks) or visual boards (Tableau)

• Experience with DCS (e.g., Delta V), SCADA, and PLC systems; and SAP, LIMS, OSIsoft PI, and/or other business systems

• 6-Sigma/Lean or similar problem-solving/decision-making methodology training

Key competencies required:

• Excellent interpersonal and communication skills

• Technological and digital curiosity

• Results and performance driven

• Adaptable and flexible

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through groundbreaking programs and policies, we empower the physical, mental, emotional,, and financial health of our employees and the ones they love. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.