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Process Scientist - 2406195654W

Description

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 https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Job Description:

J&J Innovative Medicines is recruiting a Process Scientist.

MSAT Small Molecule Drug Product is accountable for capturing and intensifying the scientific cornerstones and leading productivity, compliance, and sustainability throughout the commercial lifecycle.

As Subject Matter Expert, you will be responsible for experimental design and modeling to optimize commercial pharmaceutical processes, enhance product quality, and ensure regulatory compliance in the domain of (semi-)solid dosage forms. The ideal candidate will have a strong background in chemical engineering, computational modeling, and pharmaceutical sciences, with a passion for innovation and problem-solving.

Responsibilities

• Act as process SME supporting multidisciplinary product teams at late-stage drug product development, technical transfer, PPQ and commercial manufacturing operations by means of

o sensitivity analysis and process capability analysis.

o root cause analysis for quality, stability, and yield deviations.

• Apply scientific/engineering principles and techniques to characterize, optimize and implement processes and solve technical challenges.

• Responsible for experimental design, coordination and/or execution of lab- and pilot-scale unit operations, modelling, and statistical analysis, writing/reviewing/approving of protocols, reports and regulatory submissions.

• Collaborate with cross-functional teams on data management and the application of advanced data modelling and simulation to improve drug product & process design.

• Support initiatives for process robustness optimization and competitiveness.

• Leverage networking and influencing skills to ensure good collaboration with partners in MSAT, TDS, PES, Quality, Regulatory, MAM and DOTS.

Qualifications

Requirements

• Advanced degree in Pharmaceutics, Biotechnology, Engineering, Physics, or related area

• 3 – 5 years of experience in development of solid dosage formulations or unit operation modeling with experimental proficiency in compression and coating processes

• Strong knowledge of solid dosage manufacturing processes (batch, continuous), process control, and quality assurance.

• Experienced with unit operation scale-down model development, characterization, and scale-up

• Preferably first experience with modeling software for process simulation and optimization,

• Experience with statistical packages for experimental design and analysis or PAT-model development.

• Excellent analytical and problem-solving skills, with the ability to interpret data, identify trends, and draw actionable insights.

• Effective interpersonal and communication skills, with the ability to articulate technical concepts to diverse audiences and collaborate effectively with cross-functional teams.

• Language: English

• Ability to think critically and creatively and pay attention to detail.

• Experience with problem-solving and risk analysis methodologies.

• Good presentation and technical writing skills.

• Knowledge of regulatory requirements and guidelines related to pharmaceutical manufacturing (e.g., FDA, EMA) is preferred.

Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Organization Janssen Pharmaceutica N.V. (7555)

Job Function Technical Product Management

Req ID: 2406195654W