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Senior/ Principle Process Scientist

il y a 1 mois

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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 Sr/Princ 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**:

- Provide technical support to multidisciplinary product teams for late-stage drug product development, technical transfer, PPQ and commercial manufacturing operations by means of
- sensitivity analysis and process capability analysis.
- BP²AL assessments
- 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.
- Provide SME input to technical project reviews and operational excellence initiatives.
- Support or lead initiatives for process robustness optimization and competitiveness.
- Collaborate with TDS and MSAT expert communities to establish, maintain and deploy best practices for formulation and process development, intensification, modelling, and predictive analytics to advance the scientific foundations in SC.
- Act as a thought leader in the scientific community to impact J&J IM’s ability to build long-term value.
- 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
- 10+ years’ experience in pharmaceutical process development & optimization, and min 5 years’ experience with process modeling,
- Strong knowledge of solid dosage manufacturing processes (batch, continuous), process control, and quality assurance. Experimental proficiency in compression and film-coating processes.
- Experienced with unit operation scale-down model development, characterization, and scale-up
- Proficiency in utilizing modeling software for process simulation and optimization, and statistical packages for experimental design and analysis and 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.
- Demonstrated track record of project management, including the ability to prioritize tasks, meet deadlines, and deliver high-quality results.
- Language: English
- Ability to think critically and creatively and pay attention to detail.
- Strong networking skills to establish and participate in academic and industry network.
- 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.