Vice President

• Aug 2021 - Present

Vice President, Global Pharma Biotech Consulting in North America

• Apr 2015 - Aug 2021

Work with foreign and domestic clients in the Biopharmaceutical Device industry to do the following: • Provide general and strategic consultation. • Assist with development of quality assurance and regulatory strategies • Conducted GMP Compliance and Due Diligence assessments. • cGMP compliance audits (>75 audits performed) • Provide Person-in_planmt services to oversee operations and compliance. • Review, Development, and Implementation of Quality Systems. • Technical Writing including Validation documents, SOPs, Batch Records, CMC sections for INDs and BLAs, and responses to FDA 483 and Warning letters. o Aseptic Fill Finish o IVD o Toothpaste/Mouthwash o Biological Products o Repackaging o Technical Transfer including Project Management o Deviation investigation o CAPA Generation & Implementation o Overall Project Management o Process Validation o Facility Design Review for API and Sterile Dose Repackaging, High Potency, Cytotoxic,Hormone manufacturing, and non-sterile topicals Show less

Principal Consultant

• Sep 2009 - Apr 2015

MCS specialized in providing the following services to domestic and foreign clients in both the Biopharmaceutical and Pharmaceutical industries: • Quality System development and remediation • cGMP compliance audits (Internal and Supplier) • Manufacturing support including the following: 1. Technical Transfer including Project Management 2. Characterization 3. Deviation investigation • Technical Writing including: 1. Write &/or review Validation Documents 2. Write &/or review controlled documents including SOPs and Batch Records 3. CMC Sections for INDs and BLAs including Project Management 4. Person-In-The-Plant Services Show less

Principal Consultant

• Sep 2006 - Sep 2009

• Provided general and strategic consultation. • Assisted with development of quality assurance and regulatory strategies to ensure compliance with US and EU regulations. • Conducted GMP Compliance and Due Diligence assessments. • Provided “man-in-the-plant” services to oversee operations and compliance. • Developed and implemented quality systems. • Assisted with Regulatory submittals (IND, BLA, etc.). • Responded to FDA Regulatory Actions (FDA 483 and Warning Letters). • Performed failure and root cause investigations. • Helped to develop Quality and Operational Performance Metrics. Show less

Director, GMP Operations

• Apr 2004 - Jul 2005

Directed Manufacturing Operations for autologous cell therapy process to produce Xcellerated T Cells™ that were tested in multiple Phase I and II clinical trials. Responsibilities included development, administration, and reconciliation of operations budget. Additionally, authored relevant sections of CMC submissions to FDA and was integral member of team that participated in successful End of Phase II CMC meeting. Directed Manufacturing Operations for autologous cell therapy process to produce Xcellerated T Cells™ that were tested in multiple Phase I and II clinical trials. Responsibilities included development, administration, and reconciliation of operations budget. Additionally, authored relevant sections of CMC submissions to FDA and was integral member of team that participated in successful End of Phase II CMC meeting.

Associate Director, Manufacturing Operations

• Dec 1997 - Mar 2004

Planned, directed, and oversaw Manufacturing Operations for West Coast clinical products. Directed a staff of >50 individuals within Manufacturing Operations. Responsibilities also included budget development and reconciliation, and developing and implementing strategic staffing and manufacturing plans. Additionally: • Led the team that designed, constructed, and successfully validated a new multi-product Clinical Manufacturing Operation with >5000L of capacity. • Developed and implemented metrics for constant improvement of operations and compliance. • Directed an inaugural manufacturing campaign that was 100% successful. • Hired a team that demonstrated >95% retention in first year of operation. • Led successful inspection by state of California and subsequent licensure. Show less

Fermentation Scientist

• Dec 1993 - Dec 1997

Lead Operator

• Jul 1990 - Dec 1993