Formulation Scientist Full-time

Formulation Scientist

J&J Innovative Medicines is recruiting a 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 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 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 3 years of 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