Process Scientist
Il y a 7 mois
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.
**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.
**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
- sensitivity analysis and process capability analysis.
- root cause analysis for quality, stability, and yield deviations.
- 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.
- 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.
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