SUMMARY

Results-driven Project Manager in the biotechnology and pharmaceutical industry with 10 years of experience. Expert in overseeing Drug Manufacturing, Systems Implementations, Validation, and start ups. Specializing with Cell and Gene Therapy companies. Strong leader with a proven track record in building and motivating cross-functional teams to exceed targets. Skilled in lean manufacturing, continuous improvement, cGMP and compliance.

PROJECT EXPERIENCE

Dendreon Pharmaceuticals

Contract Manufacturing Services Project Manager 05/2021 - Present

• In order to increase Dendreon’s pipeline, we have created a new Contract Manufacturing Services department. This department leverages our Manufacturing expertise, established quality systems, regulatory consultants, doctor and apheresis network, and drug and analytical services. We have signed on two clients and have established 3 clinical products in the last three years.

• My responsibilities are divided into three categories:

• Department Readiness: Including commercial and clinical segregations, new material and personnel, facility upgrades to accommodate both autologous and allogeneic products.

• Client Relations: Utilizing marketing material to attract clients at Cell and Gene therapy conference as well as biotechnology conferences, contract development with new and existing clients, and managing tech transfers between clients and our Research and Manufacturing Sciences (RMS) groups.

• Manufacturing Services: Overseeing six cell therapy specialists ensuring Good Manufacturing Practices (GMP) and quality management systems, ensuring that products consistently meet or exceed industry standards and regulatory requirements. Identifying opportunities for process improvement, implementing Lean Manufacturing techniques, and promoting a culture of continuous improvement and a safe working environment.

• With these responsibilities, I have generated an additional $13.1 million in revenue with just two clients and three clinical products.

Dendreon Pharmaceuticals

MasterControl Validation and Implementation Project Manager 11/2019 - Present

• With Dendreon’s products produced in cleanrooms, there is a continuous need to reduce bioburden in controlled areas at two manufacturing facilities in Georgia and California. Transition from paper-based batch records to Electronic Batch Records (EBR) to reduce one of the three major contributors to bioburden.

• Managed a 10-member cross-functional team to develop, validate, and implement the MasterControl Mx (EBR) application.

• I took a hands-on approach to develop and validate the system, working closely with internal computer system validation teams and MasterControl support, identifying potential project risks, developed mitigation strategies, and evaluated the impact on project schedule.

• Using my experience in both quality and manufacturing, I was able to develop three product templates, put in place process controls and training curriculums

• Original scope did not include metric tracking modules within the system, but I was able to include implementation these modules to display Key Performance Indicators within each product, without increasing the budget or risk any delays.

• System launched two months ahead of schedule at both manufacturing sites (California and Georgia), and almost 5% under budget.

• Post Implementation tracking shows an 89% satisfaction rate by end users and 20% reduction in recoveries within the cleanroom areas.

• Ongoing: I still maintain a system admin role, evaluating direct system enhancements and quarterly updates from MasterControl, as well as providing guidance in implementation of MasterControl Qx Applications (eQMS, LMS, and DMS systems), including validation protocol developments, test script verifications, and new system configuration application/testing.

PROJECT EXPERIENCE

Dendreon Pharmaceuticals

Provenge to Asia Project Manager 08/2018 - 11/2019

• Successfully led the Provenge project expansion into the Asian market, identifying key strategic partners and establishing relationships with local stakeholders to facilitate smooth entry and growth.

• Developed and executed comprehensive project management plans, which included resources across both countries, budgeting, scheduling, and risk mitigation.

• Coordinated cross-functional teams of contractors, scientists, engineers, and regulatory experts, effectively communicating project updates, addressing roadblocks, and driving team performance towards successful outcomes.

• Managed onshore and offshore resources to minimize miscommunications and project risks between key stakeholders, and conducted regular project reviews and progress reports, analyzing data, and recommending necessary adjustments to project scope, schedules, or resources to maintain alignment with overall business objectives.

• Facility construction including cleanrooms completed three weeks ahead of schedule and on budget. Facility validation, including equipment install qualifications (IQ), Operational qualifications (OQ) and Performance qualifications (PQ), and workflows establishment completed two weeks ahead of schedule and on budget. Process establishments, E-Systems implementation, personnel training, and cFDA filing completed and submitted seven weeks ahead of schedule and on budget.

• This provided the first step in Dendreon’s expansion overseas to continue to treat mCRPC in men.

PREVIOUS WORK EXPERIENCES

ProVent Clinical Trials Project Manager Dendreon Pharmaceuticals (05/2017 – 08/2018)

Manufacturing Operations Coordinator Dendreon Pharmaceuticals (04/2016 – 05/2017)

Manufacturing Operations Associate Dendreon Pharmaceuticals (08/2014 – 04/2016)

EDUCATION

University of California, Riverside

Bachelor of Science in Bioengineering, Minor: Neuroscience and Computer Science 2013 - 2016

Orange Coast College

Associate of Science in Mathematics 2011 – 2013

CERTIFICATIONS

Project Management Professional (PMP) - Expected in 2024

Lean Six Sigma - SSGI - License# 10989893

Chemical Hygiene Certification - Dendreon Pharmaceuticals

Hazardous Waste Management - Dendreon Pharmaceuticals

Bloodborne Pathogens - Dendreon Pharmaceuticals

SKILLS

Project Management and Current Good Manufacturing Practices (cGMP):

Drug Product Development Program Management Electronic System Validation Lean Six Sigma

New Product Introduction KPI Metric Tracking Vendor Management Lean Manufacturing

Leadership/Mentorship Electronic Batch Records Continuous Improvement Process Validation

Clinical Development Commercial Manufacturing Supply Chain Management Quality System

FDA/Regulatory Experience Data Analysis Client Relations

Contact this candidate