Senior Scientist, Manufacturing Science & Technology

Description:

The Senior Scientist, MS&T, is responsible for contributing to research and development activities across the product lifecycle-from pre-formulation through product development to successful commercialization. This role contributes to the scientific and technical aspect of designing robust formulations, optimizing manufacturing processes, and ensuring seamless technology transfer.

Schedule: 8am - 4:30pm Monday to Friday

Essential Functions:

• Collaborate in the design and development of a range of pharmaceutical dosage forms, including modified-release and immediate-release oral solids and powders for suspension, contributing to cross-functional team efforts. Apply a deep understanding of formulation science, material properties, and pharmacokinetics to ensure robust product performance. Guide formulation strategies that align with therapeutic goals, regulatory expectations, and commercial feasibility.
• Write and critically review process performance qualification (PPQ) protocols and reports, cleaning verification and validation protocols, and other technical study plans required throughout the product lifecycle. Ensure all documentation meets regulatory standards and supports a state of control in manufacturing processes. Collaborate with Quality Assurance and Validation teams to ensure seamless execution and compliance.
• Implement timely execution of projects starting with the selection of raw materials, packaging components, formulation strategy, scientific development and process scale up.
• Draft comprehensive technical reports and project presentations that clearly communicate development progress, scientific rationale, and outcomes. Collaborate closely with Analytical Development, Regulatory Affairs, and Manufacturing teams to align on project goals, resolve challenges, and meet submission timelines. Evaluate analytical data to inform formulation decisions and ensure product quality.
• Provide mentorship and technical guidance to junior scientists in experimental design, data interpretation, and troubleshooting. Foster a collaborative and innovative lab environment that encourages scientific curiosity and continuous learning.
• Apply scientific creativity and critical thinking to solve complex formulation and process development problems. Leverage literature, prior knowledge, and experimental data to propose and implement effective solutions. Contribute to the preparation of regulatory documents such as ANDA submissions, ensuring clarity, accuracy, and scientific justification.
• Provide technical support for both commercial and non-commercial manufacturing operations. Troubleshoot formulation and process-related issues, identify root causes, and implement corrective actions. Recommend process improvements to enhance efficiency, yield, and product quality, contributing to continuous improvement initiatives across the organization.

Additional Responsibilities:

• Other duties as assigned.