Provide leadership and technical expertise in drug product development programs as core team member communicating project progress and timeline development.Ensure adherence to scientific/regulatory requirements, timelines, and budgets, while overseeing technical studies that facilitate further biologic drug product understanding and process development.Author technical documents to support IND, IMPD, BLA, and MAA filings.Manage CMO activities- resolve technical issues, critical documentation review, and coordination of continuous improvement for biologics manufacturing.

Ensures the compliance, upgrade/replacement, continuous improvement, and lifecycle management of Preclinical Development (PCD) enterprise and laboratory instrument/computer systems across all scientific disciplines within the PCD unit.Leads instrument/system qualification (IOP/Q) and/or validation ensuring timely planning, regulation compliance, and issue resolution to provide comprehensive PCD support.Performs surface characterization of medical devices including contact lenses, intraocular lenses, and delivery devices via scanning electron microscopy (SEM) and environmental SEM.

Novartis Biologics Technical Development and ManufacturingRepresent pharmaceutical development on CMC team (drug product lead), providing subject matter expertise in formulation and process development.Design, plan, perform and interpret scientific experiments and apply technical expertise to address complex formulation challenges to ensure preparation and timely delivery of drug product, processes, procedures, batch records and/or technical documents in support of biologics.Provide mentoring, coaching and knowledge exchange within global drug product development organization and onsite team, ensuring work is executed according to appropriate standards.

Provide strategic leadership to the process expert team formulating a compelling vision for future state of the team, establishing metrics to monitor, improve, and sustain performance.Responsible for technical deviation investigation, robust CAPA and relevant follow-up, lead product and process related investigations involving complaint, OOE, and OOS trends. Lead the process expert team to support immediate issues that occur on the shop floor during manufacturing. "Door to door,” role from raw materials to finished goods. Support and execute continuous improvement projects, improve process capability, throughput time, and waste minimization.Lead site aseptic compliance improvements within the areas of training/education, cleaning/sanitization, internal auditing, and material/component transfer.

Enhance technical transfer of drug product processes through implementation of Quality by Design (QbD) and Design of Experiments (DoE), focusing on critical processing parameters for effective process control.Aseptic process development including drug product compounding/packaging, qualification of new packaging components through media fill activities, and sterilization methods for ophthalmic parenterals.CMC leader for early development project in ocular sustained release for Glaucoma treatment to reduce medication burden and improve patient compliance.Prepare prototype formulations for research activities including stability, toxicology, exploratory studies, analytical method development and validation.

Conducted process validation and process improvement reformulation studies necessary to provide improved quality, cost, and/or efficiency.Investigated and provided direction to resolve manufacturing/packaging production issues, contributing technical input to quality investigators.Perform statistical analyses to determine process capabilities and identify areas for improvement

Evaluated, justify, and qualify new equipment and/or processes. Pneumatic weigh-dispense systems and pouch packaging equipment including: installation, cleaning/operating procedures, authoring protocol/report, and assisting in operator training.Chosen as Excedrin transfer team member yielding a collaborative effort that produced $12M saving for 2007, 44.7% COG reduction, and flexible product supply.Conduct practical problem solving training to provide leadership and fellow associates with a sustainable tool to combat process issues.Developed, wrote, and reviewed RS Batch processing software recipes for high shear wet granulation, fluid bed drying, fluid bed granulating, and film coating operations.