Bill Stretch Email & Phone Number

Bothell, Washington, Us

Seattle Genetics acquired Cascadian Rx in April 2018

Seattle, Washington, Us

Bothell, Wa, Us

CMC project team leader and Client's main point of contact. Managed large cross-functional project teams conducting GMP manufacturing and analytical laboratory services projects. Responsible to ensure all project deliverables are achieved per contract requirements. Coordinated project planning and execution of deliverables associated with process and method transfer, development, scale-up, optimization, qualification, and validation, GMP manufacturing, and stability. Managed Master Service Agreements (MSA), processed change orders, and generated invoices.

Contracted by former employer Acucela to developed clinical and financial databases for financial reporting under the Sunshine ACT. Maintained source data in reference databases, performed monthly data uploads, conducted data review, and generated report documents. (Part-time Feb14-Dec15)

Seattle, Wa, Us

Developed project plans to define project deliverables, budget, schedules, resource requirements, and risks. Managed RFPs and facilitated CRO selection. Develop project managment tools for tracking enrollment, KPIs, data monitoring, budget controls, and site payments.

Seal Beach , Ca, Us

Managed a Process Development Project Management group (1 employee, 1 contractor), and managed a portfolio of seven drug development programs in various stages of process and clinical development. - Developed, implemented, and facilitated portfolio governance process. - Managed Executive Governance Committee and director-level advisory team. - Established portfolio plans, facilitated project authorization, co-lead project teams. - Published portfolio status reports. - Developed PMO policies, procedures, and tools. Managed program and project teams. - Facilitated quarterly business review and annual product portfolio review meetings.

Kagoshima, Kagoshima, Jp

Managed the Project Management & Estimating group (9 employees) responsible for scheduling, price estimating, and monitoring of contract non-clinical studies and services. - Cross-trained groups and merged into a single project management team. - Developed and improved business systems and procedures. - Increased group productivity by > 50% and eliminated >$5 million amendment backlog. - Established business systems to track jobs, report productivity, and eliminate time lost to multiple data entry, system redundancy, and email overload. - Lead Six Sigma team assigned to create detail-level study execution process map.

Thousand Oaks, Ca, Us

Developed business models and project plans for clinical and commercial projects. Managed cross-functional process development, process transfer, and technology development teams. - Redesigned platform project plan for early drug development. Removed inefficiencies to accelerate start of clinical trials by three month and significantly reduce project cost. - Managed project teams for fourteen pipeline and commercial products. - Managed two technology development teams that improved the productivity and safety of Amgen’s drug production processes and established an ERP database for scientific data.- Assigned to create a Vectibix® project recovery plan to mitigate schedule delays. Within a two week period, I consolidated multiple data sources into a single project plan and transferred plan to site management. Achieved goal and received a performance award.

Us

Managed contract manufacturing of clinical and commercial drug product.

Us

Process, equipment, and facilities validation at owned sites.Validation oversight at contact manufacturing facilities.