Msat Sm Dp Process Pr. Scientist

Johnson & Johnson Innovative Medicine; Latina; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading healthcare company is seeking a Principal Formulation Scientist in Latina, Italy. The role requires expertise in pharmaceutical development, overseeing formulation processes, and ensuring compliance throughout the product lifecycle. Candidates should possess an advanced degree and at least 5 years of relevant industry experience. Strong analytical skills and effective communication are essential. Competitive salary and innovative work environment offered.

Competenze

• Min 5 years of industry experience in development and tech transfer of solid dosage forms.
• Strong knowledge of liquid and solid dosage unit operations and analytical release tests.
• Knowledge of regulatory requirements related to pharmaceutical manufacturing is preferred.

Mansioni

• Provide technical support for technical transfer and commercial manufacturing operations.
• Plan, design, execute, and document lab and plant studies related to optimization.
• Collaborate with expert communities in development and supply chain.

Conoscenze

Analytical and problem-solving skills

Interpersonal and communication skills

Networking skills

Technical writing skills

Formazione

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

Strumenti

Statistical packages for experimental design and analysis

Descrizione del lavoro

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

Job Function

Technology Product & Platform Management

Job Sub Function

Technology Operations Support

Job Category

All Job Posting Locations

Beerse, Antwerp, Belgium, Latina, Italy

Job Description

J&J Innovative Medicines is recruiting a Principal Formulation Scientist.

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

You will be responsible for scientific assessment and optimization of formulation & process robustness, enhance product quality, and ensure regulatory compliance in the domain of liquid and/or solid dosage forms. The ideal candidate will have a strong background in pharmaceutical development and tech transfer with a passion for innovation and problem-solving.

Responsibilities

• Provide technical support for technical transfer, PPQ and commercial manufacturing operations, including sensitivity analysis, root cause analysis, and impact assessments.
• Plan, design, execute, and document lab and plant studies related to material, formulation, and process optimization in support of commercialization and lifecycle management.
• Write, review, and approve protocols, reports, and regulatory submissions, and monitor market trends, competitive landscapes, and emerging regulations to inform strategic decision-making.
• Provide subject matter expertise (SME) to prepare and support technical project reviews and operational excellence initiatives, and support or lead initiatives for compliance, resilience, formulation, material and process robustness optimization.
• Collaborate with expert communities in development and supply chain to establish, maintain, and deploy best practices for formulation and process development and intensification, advancing the scientific foundations in Supply Chain.
• Leverage networking and influencing skills to ensure effective collaboration with partners in R&D and Supply Chain, and prepare and review relevant technical documents, such as risk assessments, change controls, regulatory submissions, deviations, validations, protocols, procedures, ...

Requirements

• Advanced degree in Pharmaceutics, Biotechnology, Engineering, Physics, or related area
• Min 5 years of industry experience in development and tech transfer of solid dosage forms
• Strong knowledge of the main liquid and solid dosage unit operations, IPC’s, analytical release tests. Practical experience with PAT is a plus.
• Proficiency in utilizing statistical packages for experimental design and analysis.
• 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.
• Strong networking skills to establish and participate in academic and industry network.
• Good presentation and technical writing skills.
• Knowledge of regulatory requirements and guidelines related to pharmaceutical manufacturing (e.g., FDA, EMA, ICH) is preferred.
• Language: English

Preferred Skills

Critical Thinking, Cross-Functional Collaboration, Empowering People, Human-Computer Interaction (HCI), Industry Analysis, Operational Excellence, Organizing, Product Knowledge, Product Lifecycle Management (PLM), Program Management, Quality Assurance (QA), Resource Planning, Service Request Management, Software Development Management, Technical Credibility, Technical Support, Technical Writing