San Francisco Bay Area
Proven technical and people leader with 25 years of experience in the biotechnology/biopharmaceutical industry focusing on antibody, cell therapy, and plasmid DNA manufacturing. Strong cGMP and compliance mindset. Strategic thinker and engineer at heart who is results- and data-driven. Thrives within a dynamic work environment through cross-functional partnerships. Legacy of people development, infrastructure building, and continuous improvement. Held positions of increasing responsibility and scope within Manufacturing, Quality Assurance, Manufacturing Sciences & Technology, Process Development/Technology Transfer, Recipe & Document Development, and Inspection Management.
- Head of Plasmid DNA (pDNA) and Biologics Process Development (PD) and Manufacturing for Contract Development and Manufacturing Organization (CDMO), department size ~40 employees, 4 direct reports. Scope included pDNA site expansion in The Woodlands, Texas for greenfield and brownfield facilities and Cell Line, Upstream, Downstream, Analytical & Formulation Development and Drug Substance (DS) Manufacturing functions in Fremont. - Led pDNA capital project achieving site selection, process definition, equipment identification and purchase approval, vendor bidding, design, hiring, and operational readiness planning to enable Research Use Only, High Quality, and GMP grade materials using 5 to 200-L scales. - Provided owner input for the design, build, and relocation of PD laboratories, equipment, and personnel in Fremont. - Drove average of >95% on-time PD milestone deliverable adherence resulting in ~75% of revenue generation for the Fremont Site over ~2-year period thru proposal, planning, and execution standardization and optimization. - Served as a technical Subject Matter Expert (SME) for due diligence evaluations for small equity investments under $5 million.
- Head of pDNA and Cell Therapy Manufacturing, department size ~15 employees, 2 direct reports. Scope included production of clinical plasmids and autologous non-viral cell therapy products. - Primary Manufacturing representative for commercial-scale facility design. Project paused just prior to permitting. - Champion for infrastructure building, continuous improvement, and communication effectiveness: Advocated targeted cross-training approach enabling >30% increase in processing capability, created the Capacity Planning Team to build resource models, assess scenarios, and facilitate scheduling, and introduced automated approaches, tools, and templates for project tracking, raw material requests, and notifications. - Spearheaded leadership and individual contributor development initiatives: Overhauled the Manufacturing Career Ladder, created development planning tools, and led leadership, collaboration, training, and recognition forums. - Reviewed and approved regulatory submission/amendment sections for Investigational New Drug (IND) Applications.
- Head of Manufacturing, department size ~25 employees, 4 direct reports. Scope included production of clinical reagents and antibody intermediates for internal and external programs utilizing single-use and stainless steel technologies for fermentation, cell-free expression, and purification. - Successfully transitioned seven products from Development to cGMP status. - Identified, implemented, and sponsored streamlining projects to gain efficiencies and create infrastructure: Increased production capacity by >65%, decreased cycle time between runs from 4 weeks to <4 days, increased yield >50%, and created resource allocation models for partner costing and headcount projections. - Compiled and reviewed regulatory submission sections for Drug Master Files and IND Applications.
- Head of QA, group size ~3 employee/direct reports. Scope included quality records management, document control, training, lot & raw material release, audits, and external QA support of DS and Drug Product (DP) contract sites for antibody drug conjugate (ADC) and bispecific ADC production. - Created and executed San Carlos Site Strategic Plan elements as the Operational Excellence and Quality Lead. - Established pre-, during, and post-audit framework for partner audit activities resulting in effective leadership and support of Conference Room, Strategy/Review Room, War Room, preparation, finding response, and commitment closure.
Recipe & Document Development (R&DD) within the Production Technology Group - Head of R&DD, department size ~30 employees, 4 direct reports, cost center budget ~$4.5 million. Scope included Manufacturing Execution Systems (MES) and SAP recipe authoring and technical writing (paper, electronic) for DS and DP, clinical and commercial products. - Drove strategic leadership development and execution activities at site and department levels. - Key Teams: Technology Leadership Team (Member), Production Services Leadership Team (Member), Electronic Execution Core Team (Sponsor), DP Business Systems Integration Team (Sponsor), and TRACK (Teamwork, Recognition, Awareness, Communication, Knowledge) (Lead).
Manufacturing Sciences & Technology (MSAT) within the Production Technology Group - Head of Bacterial Cell Culture MSAT, group size ~8 employees/direct reports. Scope included process and equipment support for bacterial therapeutics and ancillary activities, such as equipment, stock solutions, media and buffer preparation for mammalian and bacterial, clinical and commercial products. - Reviewed, approved, and/or sponsored quality records (deviations, change records, corrective and preventative actions (CAPAs)), manufacturing documentation (batch records, standard operating procedures, forms), risk assessments, and process characterization and process, equipment, and cleaning validation protocols and reports. - Compiled and/or reviewed regulatory submission sections for Biologics License Applications, Prior Approval Supplements, and Annual Reports. - SME for regulatory inspections and partner, supplier, and internal audits. - Key Teams: Bispecifics Technical Development Team (Member), Bispecifics Steering Committee (Member), Change Record Simplification (Member), CAPA Improvement (Sponsor).
Inspection Management Group within Quality - Led and supported Conference Room, Strategy/Review Room, War Room, preparation, observation/finding response, and commitment closure activities for regulatory inspections and partner and internal audits. - Managed the Genentech Plant Inspection Readiness Teams ensuring compliance risks were consistently identified, prioritized, and remediated per a risk-based methodology.