Leads an organization that performs all CMC development (DS/DP/Clinical Supply) for all clinical pipeline programs for both small molecule products and gene therapy for urologic conditions. Development programs cover a wide range of modalities such as small molecule, gene therapy and pediatric formulation.

Leads all of drug product and drug/device combination product development and manufacturing for Allakos.

Leads all drug product organization at Allakos container selection, process development, drug/device combination product development and manufacturing.

Brought lebrikizumab drug product from phase 2 through phase 3 manufacturing and commercial process validation with multiple drug/device combination product presentations (both PFS-NSD and autoinjector).Led a team that interfaced with internal stakeholders and external CMOs to ensure that:• Drug product was manufactured for internal studies, clinical trials and process validation (PPQ) and launch readiness• Drug/device combination product assembly for internal studies, clinical trials, process validation and launch readiness• Secondary packaging was selected and tested to meet patient and product requirements• Interfaced across functions to meet program deliverables and meet timelines

Quality leadership for direct materials for chemicals and excipients procured in North America, South America, and Japan● Global alignment of policies and processes● Streamlining and improvement of processes to increase value of the organization● Management of a team of Quality professionals to ensure direct material quality throughsuppliers audits, Quality processes and collaboration with suppliers

Quality leadership in development of drug/device combination products● Management of team of 3 Quality Engineers● Provided Quality oversight for development team for drug product through final packaging● Successful IND of drug/device combination product● Quality support for technical design reviews, development documentation, riskmanagement, change control, Discrepancy Management and CAPA● Development of process validation and commercial control strategies● Improvement of development business processes● Participated in selection, quality review and technical oversight of suppliers and CMOs

● Implemented drug/device combination products design controls● Conducted quality review of all MedImmune drug/device combination products● 3 Successful INDs of drug/device combination products● Collaborated with International Astra Zeneca partners to develop new drug/device combination products SOPs ● Participated in internal quality audits● Directed external audits of suppliers

● Quality leadership during corporate transition● CAPA management and resolution● Design Control● Lot Release management and approvals● Internal and external audit management● Quality Planning and Special projects

● Led a team to in-source excipient synthesis, saving company $30,000/week● Analyzed new materials or use in products during Phase 0 development● Collaborated with suppliers to improve product processes and testing● Reviewed documentation to ensure that regulatory and internal requirements were met● Wrote Chemical and Manufacturing Controls (CMC) sections for PMA submission on drug/device combination products – Resolute Integrity approved in February 2012● Audited cGMP laboratory and manufacturing facilities● Managed Process and Test Method Validations● Led new product complaint tracking and investigations● Communicated with FDA on introducing new test methods, stability data and setting specifications● Managed projects to verify and set new implantable product specifications● Introduced new test methods to save the company money and improve quality control● Contributed to Root Cause Analysis of issues during the product development lifecycle● Controlled and wrote Risk Management Reports (RMR) and FMEA for product during the design phase● Led CAPA and NCMR resolution teams