Sr. Principal, Packaging Engineering

Bachelor’s, Master’s, or PhD in Packaging Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, or a related field. 10+ years of experience in pharmaceutical or biopharmaceutical packaging engineering, supporting commercial or late-stage OSD products. Deep expertise in small molecule, oral solid dosage packaging, including bottling, blister packaging, labeling, serialization, and container–closure systems. Proven success leading packaging process development, scale-up, qualification, and validation (IQ/OQ/PQ). Strong experience with CDMO/CMO selection, technical transfer, and day-to-day management for packaging operations. Experience supporting commercial packaging operations, including launch readiness and ongoing supply. Demonstrated ability to author packaging sections of regulatory submissions (e.g., Module 3) and respond to regulatory questions. Strong understanding of global packaging regulatory expectations (FDA, EMA, ICH), including CR/SF requirements and serialization/traceability standards. Experience with packaging component qualification, compatibility studies, and packaging-related stability requirements. Experience supporting or participating in pre-approval inspections (PAIs) related to packaging. Demonstrated excellence in risk assessments (FMEA) and packaging investigation methodologies (RCA, CAPA). Effective cross-functional collaborator with strong project leadership and external partner management skills.

Lead packaging process development, scale-up, and optimization for OSD drug products. Drive CDMO/CMO selection, including technical evaluations, audits, contracting, and governance. Develop and refine packaging processes ensuring robustness, manufacturability, and compliance. Lead packaging qualification and validation (IQ/OQ/PQ) for launch and commercial readiness. Oversee packaging launch readiness, including artwork, labeling, serialization, and distribution needs. Establish and oversee commercial packaging operations ensuring efficiency, compliance, and supply continuity. Author and contribute to packaging-related sections of regulatory submissions (Module 3). Support or participate in PAIs and other regulatory interactions related to packaging. Conduct and oversee packaging component qualification, compatibility studies, and stability evaluations. Troubleshoot packaging issues, conduct root-cause investigations, and lead CAPAs. Drive continuous improvement across packaging operations, materials, and systems. Collaborate cross-functionally with Manufacturing, Quality, Supply Chain, Regulatory, Formulation, and Analytical Development.