Currently report to VP of R&D and BD• Performed interviews with key stakeholders to evaluate and assess Werfen’s PMO maturity level. • Presented mission, vision and roadmap to Werfen’s Sr. Management team to setup enterprise-level Strategic Portfolio Management Office (SPMO).• Hired one senior project manager and two project managers into current PMO.

Currently provide consulting services in the areas of strategic planning, new product development & commercialization, IVD & CDx program management, business development, pharma partnering & alliance management. Act as startup advisor, mentor and coach.

Reported to VP of PMO and General Manager of Clinical Platform. Had three direct reports. As Director and PMO executive team member, supported PMO setup and led multiple, business-critical clinical programs.• Managed BDB’s clinical reagents portfolio. Directed Leukemia & Lymphoma and Multiple Myeloma MRD programs. Received IVDR approval for multiple flow-cytometry based OneFlowTM L&L assays and launched products successfully in the European market.• As Program Director of BDB’s Companion Diagnostics initiative, led the company’s first flow-cytometry based CDx program in partnership with Ono Pharma in Japan, provided program & resource management, business development, and biopharma partnering support.• As Business Integration Lead, managed all BDB-Cytognos business integration related activities in Salamanca, Spain.

Reported to Head of PMO and to Head of Clinical Platform.• Partnered with global CROs, developed and launched cGMP antibodies for cell therapy applications.

Using multiple case studies and real-world examples, the "Foundations of Project Management" course describes the complexity of today’s project management in a global drug development effort. It will be discussed how the underlying risk markets are very challenging to manage drug development and how project management can help mitigate risk. Project success will be defined and how different types of projects may emphasize different dimensions of success. A phased approach to projects is introduced for structure and consistency. Discussions cover Project Planning and Scheduling Essentials: Critical Path and Schedule Risk Management. The course then closes with an in-depth coverage of project execution issues, including managing teams, meetings, and the psycho-social issues of project management.Key objectives of the course include:Communicate the key role of project management in the drug development success.Describe how project portfolio management guides the drug development effort to make it more efficient and effective.Learn the central project management concepts of critical path and critical chain planning and scheduling as well as detailed methods/tools that help implement these concepts.

Reported to Head of Strategic Planning & Portfolio Management. Provided strategic consulting and business management support to local site and Roche network. • Oversaw, supported and managed a portfolio of activities related to key site programs including Strategy and Goal Setting, Budget Support, Site Resource Management and Project Business Case Development. • Initiated, developed and implemented process improvement plans to enhance organizational efficiency and continuous improvement.

Reported to SVP of Product Development and had 3 direct reports. As one of the Directors of Illumina’s PMO, supported the company’s Oncology Business Unit. • Led multiple clinical programs to develop next-generation sequencing (NGS) Oncology panels for the research market (RUO) and for investigational use only (IUO). • Worked effectively with internal and external stakeholders to ensure program goals were in alignment with business objectives. Interacted with business partners, including pharma partners and CROs to ensure that all contractual obligations were met. • Implemented Illumina’s product development process (PDP) and FDA design control standards and regulations. Trained core teams on changes to the PDP process and FDA regulations.

Reported to Head of PMO. Acted as leader of cross-functional core teams, internal expert in product commercialization process, IVD project management, and communication liaison with Business Unit Management. • Led the PMA submission process for a companion diagnostics (CDx) program in collaboration with GlaxoSmithKline (GSK) to develop a gene signature assay for lung and melanoma cancer patients. • Supported multiple global programs to develop next-generation sequencing (NGS)-based tests for the oncology market in Europe. • Managed two multi-million dollar government contracts funded by the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense (DoD) to develop a qPCR-based quantitative biodosimetry assay and a rapid blood test for anthrax infection following an anthrax attack. Successfully met all contractual obligations and milestones on budget and ahead of time.

Reported to Head of Biologics in South San Francisco (SSF) and to Head of Small Molecules in Basel/Switzerland. Provided on-site leadership for global programs in the area of business process improvement and GMP optimization. Responsible for project management, training, change management and communication. • Led two cross-functional work streams in SSF and Basel to drive the completion of a detailed plan for implementation and realization of Manufacturing Science & Technology (MSAT) Improvements with the objective to harmonize manufacturing processes across the entire Roche Pharma Tech network of 21 global sites (Facility Scope: Small Molecule Drug Substance/Drug Product and Biologics Drug Substance/Drug Product).

Reported to Amgen’s Head of Program Management & Strategy.• Created workflow and implemented phase gate reviews to improve Amgen's process of preparing drug dossiers in compliance with the Academy of Managed Care Pharmacy (AMCP) format for formulary submissions.

Served the life sciences, medical devices, in-vitro diagnostics, biotech, and biopharmaceuticals industries. Provided expertise and support in the area of strategic planning, market development, business development, product development, intellectual property valuation and IVD program management. • Clients included Life Technologies Corporation, Cellpoint Diagnostics, Cellective Dx, Cellecta, SciGene, Stanford University and Swissnex San Francisco (German and Swiss start-up support).

Developed business model for a crowdfunding platform to seed fund academic biomedical research and early stage biotech projects. • Presented business plan to EuroMBA Consortium and raised €100,000 in seed capital from private investors in Europe.

As a member of SciGene’s Senior Management Team, reported directly to the company’s CEO. • Directed automation of sample preparation workflows for aCGH and next-generation sequencing (NGS). • Launched automated platform for diagnostic cytogenetic testing services ahead of schedule and installed instruments at key accounts in the U.S. • Supported effort to raise capital for new projects,

Hired into CTC as first Key Executive Director and member of Applied Imaging’s Executive Team. Played key role in Applied Imaging's turnaround and re-positioning, ultimately enabling successful sale of Applied Imaging and CTC to Genetix Group, plc, now part of Leica Microsystems (Danaher Corp.). • Directed Circulating Tumor Cell (CTC) program and launched research-use-only ARIOL CTC assay. • Supported 510(k) submission process for Her2/Neu FISH assay, resulted in FDA approval. • Presented CTC’s published & patented data as invited speaker at major International Breast Cancer Symposia (AACR, SABCS).

As member of NuGEN’s extended Executive Team, reported directly to the company's CEO. Established the company’s first product development group and had 3 direct reports. • Directed cross-functional project team to develop NuGEN’s first commercial product. • Initiated and managed global strategic partnerships and alliances, identified KOLs in the field of genomics and oncology and managed industry collaborations with life science industry leaders to support company's product strategy. • Successfully launched microarray and qPCR compatible mRNA probe amplification kit 3 months ahead of schedule and within budget. • Evaluated channel partners in U.S., Europe and Asia to distribute NuGEN's first product. • Prepared technical articles, presentations, white papers and marketing collateral. • Made critical contributions to the literature, represented the company's research at scientific conferences and at client's sites, identified and qualified sales leads at trade shows exhibits.

Reported directly to Clontech’s VP of Research & Development and had 10 direct reports. • Managed entire product commercialization process including product development, optimization, validation and product transfer to manufacturing. • Defined market opportunities for new products, initiated, directed and executed comprehensive product strategies that led to successful launch of more than 35 products. • Initiated and managed co-development programs with leading life science businesses. • Established academic partnerships and alliances with key opinion leaders in genomics and next-generation sequencing (NGS).

Performed research on transcription factors and chromatin regulation. Data were published in peer reviewed journal (EMBO J.).

Cloned and sequenced an antibiotic synthetase gene in Bacillus licheniformis.