Scientist, Engineering II, Oral Solid Dosage

Purpose

Serves as a process engineering subject matter expert responsible for the development, optimization, and technology transfer of oral solid dosage form (OSD) drug products within a pharmaceutical manufacturing environment. This position independently investigates and resolves complex manufacturing process challenges, drives continuous improvement of OSD unit operations, and supports the seamless transfer of new and existing products from R&D to global manufacturing sites and third-party manufacturers (TPMs). The role applies deep technical knowledge of OSD processing—including granulation, blending, compression, coating, and encapsulation—to ensure robust, scalable, and compliant manufacturing processes across the product lifecycle.  

Responsibilities

• Lead process engineering activities for OSD drug products, including development, scale-up, validation, and technology transfer to internal and external (TPM) manufacturing sites.
• Design, execute, and interpret process development and optimization experiments for OSD unit operations such as wet/dry granulation, high-shear mixing, fluid bed processing, roller compaction, tablet compression, film coating, and capsule filling.
• Apply first-principles engineering and Quality by Design (QbD) methodologies to establish process understanding, define critical process parameters (CPPs), and link them to critical quality attributes (CQAs) for OSD products.
• Author and review technical documents including process descriptions, batch records, validation protocols and reports, tech transfer packages, and regulatory submissions (e.g., CMC sections of INDs/NDAs/ANDAs).
• Troubleshoot and resolve manufacturing deviations, process failures, and equipment-related issues at commercial OSD manufacturing facilities through root cause analysis and implementation of corrective actions.
• Collaborate cross-functionally with R&D, Analytical Sciences, Quality, Regulatory Affairs, and Supply Chain to ensure successful product lifecycle management from development through commercialization.
• Evaluate and implement new OSD processing technologies and equipment to improve process efficiency, product quality, and manufacturing robustness.
• Develop and maintain productive working relationships with global manufacturing partners, engineering teams, and external contract organizations to support OSD product transfers and launches.
• Set and manage project timelines for process engineering deliverables; provide technical leadership and mentorship to junior scientists and engineers on OSD process-related topics.
• Routinely review and apply relevant scientific and engineering literature to advance OSD process development capabilities and identify innovative solutions to technical challenges.

 

Qualifications

• BS or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience.
• Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.
• Demonstrated ability to learn, understand and master new experimental techniques.
• Ability to multitask and work within timelines.
• Demonstrated scientific writing skills and strong verbal communication skills.
• Experience with OSD.