Supervises day-to-day operations in clinical supply manufacturing facility ensuring resources allocated properly, compliance, and area continuously inspection ready. Mentor to group of three scientists, six technicians, and one warehouse operator.• Launched a 17,000 square foot GMP Clinical Manufacturing facility, consolidating operations from 3 locations. Project team member from scope definition, through design and risk analysis, to final qualification. Team built and qualified $14.2 M facility within 21 months. • Conducted self-inspections in preparation for and subject matter expert during various internal and external inspections by local and global quality units, EU-Qualified Persons, and regulatory authorities, resulting in very few minor observations. • Defined user requirements, selected, and prepared justification memos for capital equipment to maintain optimal capacity, flexibility, and compliance with safety and cGMP requirements, including a $1.3 M contained rotary tablet press and $1.8 M contained roller compactor.

• Developed business continuity plan addressing demolition of facility for clinical supply manufacturing of highly active substances, the company’s only global capability in this area. Plan ensured continuous support of the R&D portfolio with no clinical study interruptions despite the nine month period from facility closure till qualification of new facility. • Converted toxicology order manufacturing operations from cGLP to cGMP, eliminating GLP exceptions and study delays due to last minute dose decisions and protocol approvals

Supported Technical Development Teams by manufacturing non-sterile clinical supplies per cGMP’s for Phase I and II studies. Directed the manufacture of 30-60 batches per year of tablets, capsules, powders, and liquids using a wide range of technologies including high shear granulation, hot melt extrusion, roller compaction, fluid bed processing, and tablet coating.• Gained extensive experience with design and use of state-of-the art containment isolators. Designed systems with vendors and engineering, critically reviewed mock-ups, executed SAT, FAT, and surrogate monitoring testing for 20+ isolators, allowing department to be named company’s global Center of Excellence for Clinical Supply of Highly Active Substances. Served on global Highly Active Substances Technology Working Group sharing knowledge and experiences the other Roche sites.• Prepared master manufacturing schedule for the Clinical Dosage Forms group, ensuring availability of required resources and all timelines met. Presented schedule at regular interdepartmental meetings with key stakeholders including analytics, packaging, quality management, and clinical operations personnel.• Supported operations by completing investigations as required, authoring SOPs and regulatory documents, qualifying processing equipment, and training of manufacturing personnel.• Managed transfer of processes to CMO’s and oversaw GMP manufacturing when technology not available in house.