Scientist, Engineering II
AbbVie
4 hours ago
On-site
North Chicago, IL
Operations
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. Independently investigates and resolves complex manufacturing process challenges, drives continuous improvement of OSD unit operations, and supports transfer of new and existing products from R&D to global manufacturing sites and third-party manufacturers (TPMs). Applies deep technical knowledge of OSD processing—including granulation, blending, compression, coating, and encapsulation—to ensure robust, scalable, and compliant manufacturing processes.
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) to establish process understanding, define critical process parameters (CPPs), and link them to critical quality attributes (CQAs).
- 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 issues using root cause analysis and corrective actions.
- Collaborate cross-functionally with R&D, Analytical Sciences, Quality, Regulatory Affairs, and Supply Chain for lifecycle management from development through commercialization.
- Evaluate and implement new OSD processing technologies and equipment to improve efficiency, quality, and robustness.
- Develop and maintain relationships with global manufacturing partners, engineering teams, and external contract organizations to support transfers and launches.
- Set and manage project timelines for deliverables; provide technical leadership and mentorship.
- Routinely review and apply scientific/engineering literature to advance capabilities and identify innovative solutions.
Qualifications
- BS (or equivalent) with typically 7+ years of experience, or MS (or equivalent) with typically 5+ years of experience.
- Ability to independently design, execute, and interpret critical experiments.
- Ability to learn, understand, and master new experimental techniques.
- Ability to multitask and work within timelines.
- Strong scientific writing and verbal communication skills.
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. Independently investigates and resolves complex manufacturing process challenges, drives continuous improvement of OSD unit operations, and supports transfer of new and existing products from R&D to global manufacturing sites and third-party manufacturers (TPMs). Applies deep technical knowledge of OSD processing—including granulation, blending, compression, coating, and encapsulation—to ensure robust, scalable, and compliant manufacturing processes.
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) to establish process understanding, define critical process parameters (CPPs), and link them to critical quality attributes (CQAs).
- 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 issues using root cause analysis and corrective actions.
- Collaborate cross-functionally with R&D, Analytical Sciences, Quality, Regulatory Affairs, and Supply Chain for lifecycle management from development through commercialization.
- Evaluate and implement new OSD processing technologies and equipment to improve efficiency, quality, and robustness.
- Develop and maintain relationships with global manufacturing partners, engineering teams, and external contract organizations to support transfers and launches.
- Set and manage project timelines for deliverables; provide technical leadership and mentorship.
- Routinely review and apply scientific/engineering literature to advance capabilities and identify innovative solutions.
Qualifications
- BS (or equivalent) with typically 7+ years of experience, or MS (or equivalent) with typically 5+ years of experience.
- Ability to independently design, execute, and interpret critical experiments.
- Ability to learn, understand, and master new experimental techniques.
- Ability to multitask and work within timelines.
- Strong scientific writing and verbal communication skills.